Senior Manager, Regulatory Affairs Resume Samples

The Guide To Resume Tailoring

Guide the recruiter to the conclusion that you are the best candidate for the senior manager, regulatory affairs job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

Craft your perfect resume by picking job responsibilities written by professional recruiters

Pick from the thousands of curated job responsibilities used by the leading companies

Tailor your resume & cover letter with wording that best fits for each job you apply

Resume Builder

Create a Resume in Minutes with Professional Resume Templates

CHOOSE THE BEST TEMPLATE - Choose from 15 Leading Templates. No need to think about design details.

USE PRE-WRITTEN BULLET POINTS - Select from thousands of pre-written bullet points.

SAVE YOUR DOCUMENTS IN PDF FILES - Instantly download in PDF format or share a custom link.

Create a Resume in Minutes

M Stark

Moshe

Stark

416 Witting Land

Houston

+1 (555) 642 5608

416 Witting Land

Houston

Phone

p +1 (555) 642 5608

Experience Experience

Chicago, IL

Senior Manager Regulatory Affairs

Chicago, IL

Botsford-Weber

Chicago, IL

Senior Manager Regulatory Affairs

Ensuring that checking and auditing procedures are carried out
Manage interactions with FDA on CMC issues
Assist in the review and policies and procedures
Ensuring that the new product registration is performed on time before the launch
Develop and recommend regulatory strategies
Serve as Regulatory Affairs representative on facility/site Local Change Management Boards
Collaborate with Device Regulatory International personnel who perform EU based (legal manufacturer) registrations

New York, NY

Senior Manager, Regulatory Affairs

New York, NY

Ortiz LLC

New York, NY

Senior Manager, Regulatory Affairs

Develops content of regulatory documents working with other functions as necessary & contributes to review of documents before submission
Manages departmental spending to the established budget
Write and/or edit process documents using RA templates, or create new templates in support of continuous RA process improvement
Develop a product regulatory timeline aligned to the company’s product development, with key regulatory milestones, and activities for agency filing
Support process improvement initiatives, standards development, and metrics
Assist in development of regulatory standards and SOPs
Provide regulatory guidance to support business development and sales

present

Chicago, IL

Senior Manager, Regulatory Affairs CMC

Chicago, IL

Stracke-Feil

present

Chicago, IL

Senior Manager, Regulatory Affairs CMC

present

Serve as functional CMC representative on assigned New Product Development teams and related technical task forces as well as In-Line projects such as site transfers
Work to align with the RA Technical Director to research and prepare the initial CMC strategy for timely registration of New Product with FDA, EMA and other world Regulatory Authorities
Serve as functional CMC representative on assigned New Product Development teams and related technical task forces as well as Lifecycle management projects such as site transfers
Provide regulatory assessments of manufacturing changes within the change control system and filing strategy guidance to Technical Operations and Quality department, including supporting preparation for facility inspections of vendor sites by health authorities when necessary
Initiate local process improvement and contribute to local and/or global process improvements which have significant impact for the Regulatory Affairs Department or other departments
Manage relationships with key stakeholders in technical Operations and Quality and across Regulatory Affairs to provide CMC regulatory support in achieving strategic objectives
Work with functional experts to provide timely responses to CMC questions from regulatory agencies

Education Education

Bachelor’s Degree in Science

Rutgers University

Bachelor’s Degree in Science

Skills Skills

Knowledge of applicable regulations, current industry practices, and strong experience with interpretation and application
Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
Excellent scientific knowledge and technical system skills
Demonstrated strong organizational skills with ability to set priorities and meet deadlines, as well as to respond to changing deadlines and priorities
Strong attention to detail
Actively engages in professional development
Microsoft Office/Suite proficient (Word, Excel, PowerPoint, etc.)
Regulatory knowledge in national regulations
Great interpersonal skills
Excellent communication skills (written and verbal)

Create a Resume in Minutes

15 Senior Manager, Regulatory Affairs resume templates

Read our complete resume writing guides

Senior Manager, Regulatory Affairs Resume Examples & Samples

2+ years of Regulatory Affairs experience
Bachelor's Degree in Life Sciences or Pharmaceutical
Extensive experience in CMC Regulatory Affairs
Experience in global Regulatory Affairs/Drug Development including direct interactions with FDA
Experience with the preparation and review of regulatory submissions
Experience with electronic submissions and knowledge of CTD and eCTD
Microsoft Office/Suite proficient (Word, Excel, PowerPoint, etc.)
Able to multitask efficiently and effectively $
Advanced Degree in Life Sciences or a Health-related field
Background in Chemistry, Manufacturing and Controls Regulatory Affairs
Experience in biologics/biotech drug development projects in immunology, oncology, rare diseases, or renal disease
Prior interactions with regulatory agencies

Senior Manager Regulatory Affairs EU Resume Examples & Samples

Lead SRA responsibilities on food regulatory developments for the EU including
Continuous monitoring of the regulatory environment (early warning)
Leading the development of positions on EU food regulatory initiatives and facilitating internal alignment in close collaboration with relevant BUs and other relevant functions in Europe and within Corporate
Actively influencing along the process in all stages and with all relevant stakeholders, communicating developments internally and governing of markets regarding impact, changes and implementation
Maintain, enhance and develop strategic relationships/networks with external experts & stakeholders such as EU Institutions, NGOs, academics, industry and other stakeholders on issues relating to food regulatory matters to advance our company positions and create a favourable regulatory landscape
Provide support and expert input on critical scientific and regulatory issues (i.e. regulatory and compliance matters, regulatory opportunities) in specific countries (also outside of EU where EU legislation has a significant impact)
Proactively identify, develop, and execute initiatives, programs, partnerships, coalitions and stakeholder networks, with the objective of minimizing regulatory and scientific barriers and/or leverage regulatory and scientific opportunities to support our renew growth strategy. Actively represent TCCC at key regulatory discussions in industry associations/coalitions on nutrition and health as well as food safety regulatory/policy matters s to help protect our products and ingredients
Leverage cross-functional relationships, particularly with PAC, Legal, R&D, Technical governance, Marketing and other functions as appropriate in support of our renew category growth strategy and in order to drive our related scientific and regulatory strategy and initiatives
Proactively support innovation plans and identify regulatory opportunities for the successful growth of the TCCC system
Drives cross-discipline collaboration and teamwork: Applies understanding of scientific & regulatory processes, including internal and external relationships to advance to advance achievement of company’s and technical organization’s priorities. Demonstrated ability to establish and nurture productive cross-functional and internal and external stakeholder collaborations
Problem Analysis and Resolution: Ability to form an opinion or make a decision through careful testing of assumptions and facts; willingness to take action consistent with available facts, constraints and probably consequences
12+ years with MS, or 10+ years with PhD in food science, nutrition or related field and relevant experience
Profound knowledge and experience in EU food law and regulatory matters

Senior Manager, Regulatory Affairs Resume Examples & Samples

A minimum of a Bachelor’s degree is required, preferably in a Life Sciences related discipline. An advanced degree (MS, MBA, PharmD, MD, PhD, etc) is preferred
Minimum of 8 years of relevant experience, preferably within a Regulatory environment
Experience within Medical Devices, Pharmaceutical, and/or Consumer industries preferred
Minimum 3 years demonstrated ad & promotional review experience is required
Previous leadership or supervisory experience is required
Advanced level of written and oral communications skills is required
Demonstrated knowledge of medical device advertising requirements in the US and EU is preferred
Ability to work in a fast paced environment, and juggle multiple projects; strong organizational skills; ability to work independently is required
Ability to influence others to understand and comply with regulatory requirements is required
Excellent problem solving skills, ability to think creatively within established guidelines is required
Ability to work with a diverse set of stakeholders in different geographical regions, interpret difficult situations, and determine optimal solutions to ensure customer satisfaction is required
This position is located in Wayne, PA and may require up to 10% travel, domestic and international

Senior Manager Regulatory Affairs Resume Examples & Samples

A minimum of a Bachelor’s Degree in a scientific/technical/engineering related discipline or equivalent degree is required
A minimum of 8 years of Medical Device industry experience or related industry experience is required
Highly skilled in establishing partnerships with internal and external partners and the ability to work collaboratively in a matrix environment is required
Masterful communication, organizational, negotiation and interpersonal skills are required
Expert knowledge and hands on experience obtaining regulatory approvals for medical devices is required
Strategic Thinking with demonstrated ability to set effective business, technical and/or regulatory direction is required
Proven record of effectively negotiating and influencing upper management, affiliates, regulatory agencies, and industry to ensure that regulatory and business needs are met is required
Must be able to communicate clearly and effectively over the phone and in written in English
Experience in the field of optometry and contact lenses is a plus
This position is located in Jacksonville, FL and may require up to 15% domestic and international travel

Senior Manager, Regulatory Affairs Resume Examples & Samples

Develop and communicate Global UDI requirements and provide ongoing global regulatory labeling strategies and plans for complex UDI implementation programs as well as new product development. Integrate key labeling requirements and best practices into global UDI and labeling strategies
Help formulate and drive global UDI initiatives as well as global labeling traceability requirements within project and product teams
Represent or lead the RA labeling function on assigned cross-functional project teams and projects. Contribute independent ideas and help guide the overall effectiveness of the cross-functional labeling team
Monitor applicable global regulatory and labeling requirements; assure compliance with Baxter and external standards and help drive implementation across functions and projects
Effectively perform gap analysis and propose solutions. Develop and document sound regulatory decisions and justifications
Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
Strong oral and written communication and presentation skills
Ability to independently identify compliance risks and escalate when necessary
Ability to lead and coach others
Bachelor’s degree or country equivalent in related scientific discipline with a minimum of 5-7 years regulatory experience in RA or related field, including managing people or projects. Direct experience with global device labeling will be an advantage

Senior Manager Regulatory Affairs Resume Examples & Samples

Establish company policy to ensure that the company meets the regulatory requirements for Medical Devices products sold onto the Asian Market
Setting strategy and direction for the team and also looking at the compliance aspects for the different regions in Asia
Ensuring that the new product registration is performed on time before the launch
Ensuring the product meets all legal obligations for sale in Asia like Product regulations, registration, labeling and barcode
Work closely with government bodies, regulatory authorities and associations, International standard Organizations (ISO)
Carrying out ISO audit of facilities such as 3rd Party Warehouse and related areas
Participate in due diligence of acquisition for product regulatory compliance
Ensuring active membership of design teams for Pall Medical and Pall International product to ensure that regulatory requirements are met in the design phase
Ensuring that subcontractors meet regulatory compliance requirements and are approved by regulatory affairs at the initiation stage
Degree in Biology, Chemical, and Polymer related studies
Hands on experience in ISO procedures would be a big plus
Prior experience in Regulatory affairs and quality assurance
Willingness to travel across Asia
Good team player and ability to work in an autonomous manner
Ability to manage the team virtually

Senior Manager Regulatory Affairs Resume Examples & Samples

Formulate, lead and drive CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance
Identify as early as possible, the required documentation and any content, quality and/or timeline issues. Negotiate the delivery of approved technical source documents in accordance with project timeline
Coordinate with Regulatory Operations to ensure timely and accurate submissions to Regulatory Authorities
Review and provide input on proposed health authority guidance documents on CMC issues
8+ years pharmaceutical industry and 6+ relevant regulatory CMC experience
Advanced degree highly preferred ( MS, Pharm.D, Ph.D. or equivalent)

Senior Manager, Regulatory Affairs Resume Examples & Samples

Responsible for developing product regulatory strategy for surgical devices
Develop a product regulatory timeline aligned to the company’s product development, with key regulatory milestones, and activities for agency filing
Coordinate with the team on the development of product labels in accordance with regulatory requirements
Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions
Manage interactions with other Bausch & Lomb functions (e.g., Quality, Compliance) during Regulatory Authority inspections
Provide regulatory guidance/input to surgical device change control and internal product review boards
10+ years relevant medical device industry and regulatory experience; 5 + years in Class II and III devices
Ophthalmic device regulatory experience, a plus
Bachelor’s degree in science or health related field; advanced degree a plus (PhD, MD, MS, PharmD, or equivalent)

Senior Manager Regulatory Affairs Resume Examples & Samples

Supervise, evolve and track integrity of audit of Quality System (DIN ISO standards 9001 and 13485) within internal organization and of external service provider including the customer service organization with more than 100 agents working on behalf of Abbott at SITEL
Builds sustainable Regulatory Affairs, Quality & Compliance infrastructure for DACH by developing policies, procedures and guidelines in consultation with GM, Global QA/ RA team
Liaises with global and communicates local regulatory requirements and ensures appropriate implementation in line with external and internal requirements
Supports evolution of ADC business critical transformation to a direct-to-consumer and direct-to-patient business actively establishing and implementing new appropriate quality standards according to internal and external regulatory standards
Contributes to evolution of our Quality System MIMS (Multisite Integrated Management System) to ensure it appropriately supports DACH regulatory and business requirements
Supports GM Germany in ensuring ADC meets local compliance standards of Environmental, Health & Safety (EHS), Affiliate Compliance Committee (ACC) requirements and other legal requirements. Drives critical improvements in compliance management analyzing changes in local regulatory framework. Interacts with EHS department and Compliance Manager
Manage business critical field actions coordinating relevant teams including functions from sales, marketing, medical, customer service, regulatory and public affairs
Ensure preparation of any internal or external Regulatory or Quality Audit
Degree in Natural Science, Medicine or Engineering
Knowledge of regulatory requirements (e.g. MPG, IVD guideline), internal & external compliance regulations and quality standards
Extensive project management experience
Solid know-how in Regulatory, compliance and quality affairs of diagnostic, pharmaceutical or medical device industry, execution and documentation of field actions
Working Experience in a commercial organization with a strong customer focus
Ideally knowledge of the diabetes market
Organizational skills and high level of quality awareness
ONESTEP & other internal quality management systems (ETMS, etc.)
Ability to lead cross functional teams under tight timelines
Effective and motivating interpersonal communication skills

Senior Manager, Regulatory Affairs Resume Examples & Samples

Responsible for, or contributes to execution of development & submission strategies in EU for projects assigned
Works with Regulatory Strategy Leader & Regulatory Projects Team leadership to ensure that development programs & product life-cycle plans are aligned with regulatory requirements
Contributes ideas to the design of innovative regulatory pathways
Supports Regulatory Projects Team Leadership on development of regulatory tactics to be communicated to internal stakeholders, e.g. GPT as requested
May interface between global & regional headquarters to ensure both parties are kept updated on regulatory progress & operational issues. Participates in global regulatory Therapeutic Area (TA) team
Develops & contributes to the development of high quality regulatory dossiers (e.g., scientific advice requests, orphan medicinal product designation applications, MAAs & variations), ensuring compliance with regulatory requirements
Develops content of regulatory documents working with other functions as necessary & contributes to review of documents before submission
Reviews draft protocols, acts as Regulatory Project Team representative in clinical study teams and liaises with the Clinical Trials Applications (CTA) group
Acts as subject matter expert on designated studies in the event of a Health Authority inspection
Responsible for tracking & communicating regulatory activities within RA & for accurate submission plans in eQRMS
Responsible for or participate in interactions with Regulatory Authorities, including agency meetings
Supports or is responsible for the optimisation of product information achieved through negotiation with internal stakeholders & Regulatory Authorities
Supports or may be responsible for ensuring that Celgene fulfils Health Authority commitments
Participates in regional launch team
Responsible for the regulatory review & approval of commercial advertising & promotional literature
May be responsible for leading, managing & coaching Regulatory Projects Team staff as assigned
Monitors resource needs for projects assigned through discussion with manager
May contribute to planning & monitoring the budget for the TA Regulatory Projects Team
May participate in cross-functional initiatives
LI-SL1
PHW
Experience in EU Regulatory Affairs & recent experience of EU Centralised Procedure required
In-depth knowledge of current EU regulatory requirements essential
In-depth understanding of CTD modules; non-clinical, CMC, Clinical
Thorough understanding of core processes of drug discovery, development, manufacturing & marketing required
Knowledge of TA for projects assigned
Experience of leading projects through Regulatory Procedures
Experience in Haematology/ Oncology or Inflammation/ Immunology preferred
Experience of contributing to Ph III protocols & able to contribute to clinical development plans
Actively engages in professional development
Seeks opportunities to learn from others
Effective project manager, developing leader. Creates project plans, prioritises effectively, leads teams in project execution & delivery
Ability to lead complex regulatory submissions. Leads activities for assigned projects
Conveys trust in others’ knowledge, skills & judgment & provides team members with appropriate levels of autonomy & decision-making authority
Displays a willingness to challenge the status quo & take risks
Acknowledges others who take the initiative to try new approaches even if the results are not perfect
Identifies when to escalate issues to line management & knows when to seek advice
Communicates complex ideas effectively across a culturally diverse environment
Communicates effectively with Regulatory Authorities as required
Ability to influence internal & external stakeholders to obtain desired outcome
Exhibits consistent professional behaviours

Senior Manager Regulatory Affairs Resume Examples & Samples

Act as Regulatory Project Lead but may also report to another Regulatory Project Lead as required
To be familiar with and to work in accordance with relevant ICON SOP’s and internal systems, GXP and appropriate regulations and guidelines
As a manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken
Management of the designated project in accordance with the agreed project planning and control documentation, including initiation and maintenance of the project plan
Management of the assigned regulatory project team
Ensuring that checking and auditing procedures are carried out
Monitoring and advising on compliance with agreed budget relating to the project
EU/APAC: In depth proven experience in regulatory affairs or aligned work
Good written and spoken English
Bachelor’s degree, or local equivalent, preferably in the sciences, or equivalent experience qualification. Masters degree or higher preferred

Senior Manager, Regulatory Affairs Resume Examples & Samples

Function as global CMC lead on program teams
Strategize on deliverables to ensure Module 3 content meets regulatory requirements
Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans
Collaborate as a trusted and respected peer with R&D, CMC teams, Manufacturing and Quality Assurance to establish appropriate risk-based solutions which account for regulatory requirements
Work to integrate regulatory CMC requirements and expectations throughout the organization
Serve as lead CMC regulatory representative on cross-functional product teams, and applying advanced knowledge of regulations and interprets technical regulatory guidelines to ensure that regulatory submissions are in compliance with government regulations
Participate at the global regulatory teams representing CMC and participate in regulatory authority meetings for major CMC meetings
Oversee development and negotiation of overall plans regarding CMC to assure viability for global or regional registrations for select program
Align CMC regulatory strategy to overall regulatory business strategy
Interpret new regulatory policies and trends and as they apply to company products and procedures for impact and/or potential change in approach
Knowledge of applicable regulations, current industry practices, and strong experience with interpretation and application
Excellent scientific knowledge and technical system skills
Excellent risk management discipline and problem solving skills
Ability to function as a team member and lead where needed
Experience in interacting with Regulatory Authorities
Bachelor’s degree or country equivalent in pharmacy or related scientific discipline with a minimum of 7 to10 years of regulatory or equivalent experience or PhD with 3years within a pharmaceutical company
Experience with registration of Monoclonal Antibody applications with regulatory agencies are highly required
Experience in quality or contract manufacturing environment and regulatory inspections and audits

Senior Manager, Regulatory Affairs Resume Examples & Samples

Regulatory Affairs (RA) team lead on software development project core teams
Manage product regulatory submissions as part of the Corporate Headquarters Regulatory Affairs team
Work with regulatory colleagues to develop innovative regulatory strategies for New Products (NPI) to drive business growth; assist markets in product registration planning, claims assessment and innovation, developing registration dossiers for submission, monitoring the progress, status and timelines
Participate as the regulatory subject matter expert during audits or inspections to ensure compliance with relevant product regulations (e.g., compliance with US FDA QSR, Europe IVDD/MEDDEV, Canada Med Dev Regulation, ISO 13485 & 14971, etc.)
Compile evidence, prepare, submit and track annual reports according to requirements of regulating bodies
Monitor and assess design and process changes – with emphasis on IVD software – for regulatory impact
RA team lead in compiling and preparing hardcopy and electronic information packages for submission to regulatory agencies
Define, monitor and receive deliverables for submissions
Interact with regulatory agencies and third party accrediting bodies
Write and/or edit process documents using RA templates, or create new templates in support of continuous RA process improvement
Monitor advertising and promotional materials for compliance with product claims
Provide regulatory guidance to support business development and sales
Provide training and updates on key regulatory legislation, systems, processes and/or projects (as appropriate)

Senior Manager Regulatory Affairs Resume Examples & Samples

Independently manage multiple projects and submissions primarily for Alexion’s commercial and investigational products
Plan, coordinate, and manage the development, preparation and submission of the Chemistry, Manufacturing, and Controls (CMC) sections of Alexion’s registration dossiers, supplements, and renewals for commercial products. Dossier preparation will include new country submissions and post-approval changes
Develop proactive regulatory strategies for global CMC product lifecycle management, with limited oversight. Present CMC strategies and plans to Alexion management and appropriate core teams
Effectively build and lead project teams for CMC submissions
8-12 years related experience in a scientific discipline with additional technical / project education or training; with a minimum of 5 years of experience in Regulatory, Regulatory-CMC or a Quality Compliance function

Senior Manager Regulatory Affairs Resume Examples & Samples

Identify as early as possible, the required documentation and any content, quality and/or time-lineissues. Negotiate the delivery of approved technical source documents in accordance with project time-line
Knowledge of pharmaceutical industry regulatory affairs CMC discipline throughout the product life-cycle, with awareness of pre-clinical, clinical, commercialization, and operations
Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks
Demonstrated ability in analytical reasoning and critical thinking skills
Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
Demonstrated ability to contribute to a continuous learning and process improvement environment
Capacity to react quickly and decisively in unexpected situations
Advanced degree highly preferred ( MS, Pharm. D., Ph.D. or equivalent)

Senior Manager Regulatory Affairs Amac Resume Examples & Samples

Develop and drive regional regulatory strategies for New Product across AMAC in close collaboration with the respective Sub-region Heads
Identify opportunities and challenges to meet submission & approval targets in order to ensure successful launch
Partner with Sub-region heads to implement set plans and to develop mitigation plans when appropriate
Provide Subject Matter expertise in product development for assigned portfolio to region and in regional requirements to global development organization
Provide comprehensive regional regulatory input into global Regulatory Functional Plan, ensuring key country specific requirements (e.g. local patients, bridging reports, GMP inspections, etc.) are known and considered early enough during drug development to meet business targets as planned
Partner with regional commercial organization to ensure business objectives are understood and taken into account during development of regulatory strategy. Provide comprehensive regulatory advice impacting commercial planning
Identify and leverage opportunities for cross-country, cross-regional cooperation and synergies with Sub-region Heads
Act as Primary AMAC Lead for key stakeholders in global regulatory franchises (with GPRMs and GPRDs) and AMAC commercial colleagues for assigned portfolio
Liaise with global RA teams and/or regional commercial organization to ensure the necessary support to countries to execute regional strategies
‘Translate’ complex global development information into tangible actions and strategic considerations for countries and sub-region heads
Represent RA AMAC in Regulatory sub-teams for key projects/products and provide relevant regional input
Ensure transparent, complete and timely communication to regional team, management and key stakeholders
Facilitate Best Practice sharing across region and with other regions
Deliver capability building and training opportunities to countries within region
Partner with Sub-region Heads to increase regional regulation awareness within global organization
Minimum 5 years’ experience in Drug Development. In depth Regulatory experience preferred
Deep understanding of regulatory environment in region an advantage
Ability to work in cross-functional, multi-cultural environment
Highly committed and team-oriented
Excellent communication and negotiation skills
Ability to develop and communicate regulatory strategy
Shows cultural awareness
Strong analytical skills, strategic thinking
Experience with Asia, Middle East and/or Africa an advantage

Senior Manager, Regulatory Affairs Resume Examples & Samples

FDA, SOP and cGMP standards, guidelines and regulatory compliance regulations
Pertinent Federal and State laws related to pharmaceutical regulatory affairs
Supervision and training practices and methods
Business, scientific and personal computer software applications
Business English usage such as, spelling, grammar and punctuation
Recruiting, interviewing and selecting of applicants in accordance with established employment practices and methods
Company policies, practices and procedures, including safety rules and regulations
Principles and practices of budget preparation and administration

Manager / Senior Manager Regulatory Affairs Resume Examples & Samples

PharmD/BS degree in a scientific discipline
Minimum 8 years pharmaceutical industry experience: 5+ years Regulatory Affairs required coupled with 2 years Analytical, QA, laboratory, or production experience preferred
Minimum 3 years pre-approval Regulatory experience with ANDA or 505(b)1/505(b)2/351(a) and/or 505(j) applications is required
Previous 510K experience is preferred
Injectable/sterile product experience required; however, BLA/Biosimilar experience will be considered
Previous Managerial experience preferred
Exhibits strong knowledge of current regulations and guidances related to the filing, approval process, and maintenance of ANDAs
Demonstrates a basic understanding of pharmaceutical drug development
Basic computer skills such as Word, Excel, Power Point, and familiarity with the internet
Ability to manage timelines within a project team environment
Ability to work independently and on teams
Ability to effectively liase with FDA, various disciplines within Teva, and third parties
Ability to establish and maintain good working relationships
Demonstrates good negotiation and management skills
Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities

Senior Manager, Regulatory Affairs Resume Examples & Samples

Provides direction and leadership to facilitate market clearance and product registration activities for product commercialization within North and South America
Executes all registration and licensing requirements as they apply to products and services of the company both domestically and internationally, as well as facility licensing activities
Provides early guidance concerning regulatory requirements, e.g., submissions, claims identification and substantiation, labeling, promotional materials and assuring the validity of clinical, ethical and regulatory compliance issues
Reviews and approves all labeling for compliance, including all communications to trade publications, news media release, sales presentations and technical bulletins
Analyzes the support data for claims verification
Collaborates with and assists Global Regulatory partners to support product compliance internationally
Manages departmental spending to the established budget
Manages Regulatory Affairs/Quality Systems Department budget
North and South America regulatory responsibility, but interfaces with global team
Span of control: Document and Data Control, Regulatory Affairs (Americas), FDA Official Correspondent
Span of influence: R&D input related to US and Canadian registrations, Global Regulatory Affairs (consults/coordinates on global regulatory licensing and registration strategies)
Direct reports may include Documentation Specialist(s), Regulatory Affairs Associate(s), and Regulatory Complaints Specialist(s)
Trust and Integrity
Negotiation/Influence
Managing Others
Global/Business Perspective
Computer Skills – Proficient computer system based tools including Microsoft Office applications, presentation, e-mail, web browsers and spreadsheet software
Minimum of 8 years of Regulatory experience in the food, drug, or device industry required
History of success in making change and achieving objectives required
Successful track record working in a matrix/collaborative environment required

Senior Manager, Regulatory Affairs Resume Examples & Samples

Support the program EU regulatory leads in executing on program strategy and deliverables, may take the lead on the strategy and execution of deliverables for one or more programs as required by the needs of the business and the EU regulatory team
Ensure European regulatory requirements are identified and implemented into development and pre and post-authorization regulatory activities
Contribute to the strategy, planning, preparation, submission and maintenance of MAA’s, CTA’s, ODD’s, PIPs, Regulatory Agency meetings, Protocol Assistance etc as required for assigned programs
Represent the EU RA department in cross-functional project teams, engage with and give regulatory support to program regulatory and development teams, and commercial, medical and clinical colleagues
Support process improvement initiatives, standards development, and metrics
Interact with staff from EMA and other EU national agencies
Provide guidance to all appropriate departments in BioMarin to ensure compliance with applicable regulations
Remain knowledgeable about current and evolving EU regulations and guidance
Extensive regulatory experience gained within a Pharma/Biotech Company or with an EU regulatory authority
Experience of both development and pre-/ post-authorization activities, in particular with a track record in execution of strategy for development products
Orphan drug experience is preferable
Skilled at gathering supportive information and developing EU regulatory approaches for development and pre- and post-authorization activities,
Proven ability to manage critical projects as a part of a multifunctional (matrix) team
Proven ability to successfully interact with regulatory authorities
Prior experience managing regulatory submissions with the ability to successfully manage projects to deadlines
Ability to multitask; manage multiple products and deliverables and independently resolve problems and identify areas of opportunity
Proficient with computer and standard software programs. Experience with electronic submissions such as eCTDs and working with an electronic Document Management System is desirable
Outstanding interpersonal, negotiation and communication (written and verbal) skills

Senior Manager, Regulatory Affairs Ad / Promo Resume Examples & Samples

Supports interactions with the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) for assigned product(s)
With oversight from Director level or above, develop regulatory strategies and provide guidance to other departments
Manage timelines and resources to achieve stated goals
Foster and facilitate teamwork between Regulatory and CRC partner functions
Provide regulatory advice and support to commercial teams and the Copy Review Committee (CRC), with oversight
Develop departmental guidance and procedures
Manage regulatory aspects of the copy review / approval process for product promotional materials for assigned products, indications, or audiences. Ensure compliance of promotional materials with the governing FDA regulations, and ensure submission of promotional materials to OPDP in a timely fashion
Design and conduct departmental training
Monitor and interpret promotional labeling regulations and guidelines for the successful and compliant commercial marketing of Celgene’s pharmaceutical products. Pro-actively monitor the latest regulations, guidance, and actions from the FDA and competitors that may influence the landscape
Bachelors degree (BA or BS). Scientific discipline preferred
3-7 years of pharmaceutical industry experience, with 2-4 years in regulatory affairs preferred
Knowledge of FDA advertising and promotional regulations and guidance is necessary
Must be able to innovate, analyze, and solve problems with minimal supervisory input
Excellent communications, listening, and negotiation skills are necessary
Leadership skills required
Excellent organizational, and time management skills needed to manage multiple ongoing projects simultaneously
Must be an innovator of new ideas and best practices
Must recognize potential problems
Must have outstanding attention to detail
Domestic travel may be necessary

Senior Manager, Regulatory Affairs CMC Resume Examples & Samples

Serve as functional CMC representative on assigned New Product Development teams and related technical task forces as well as In-Line projects such as site transfers
Participate in Project team and lead technical task force meetings leading on RA/CMC related activities
Work to align with the RA Technical Director to research and prepare the initial CMC strategy for timely registration of New Product with FDA, EMA and other world Regulatory Authorities
Provide leadership to rapidly adapt strategy to unanticipated changes
Lead and coordinate the timely compilation and critical review of the CMC data package from other functional team representatives to provide complete and appropriate documentation necessary for timely world-wide registration
Work with functional experts to provide timely responses to CMC questions from regulatory agencies
Support transfer of manufacturing processes and analytical methods from R&D to Industrial Operations
Writes CMC dossier from CMC data package and coordinate a comprehensive project team review by functional team members to ensure accuracy of the filed dossier
Participate in and manage post-approval product activities such as, but no limited to, change control, supplements and variations for global products as well as questions from regulatory authorities where appropriate
Provide regulatory CMC expertise during Regulatory Affairs negotiations and interactions with regulatory agencies
As CMC Technical representative to assigned New Product Development teams, communicate with internal and external customers to obtain required supporting documents and data for compilation of the CMC dossier in a timely manner that supports agreed upon project timelines
Coordinate and lead the task of drafting responses to CMC related questions from FDA or foreign health authorities
Represent Merial position and interests in external trade organizations or regulatory professional societies. Keep up to date on industry and regulatory trends
Provide regulatory CMC expertise during due diligence and in support of new projects
Ph.D. with four years experience or Master Degree with six years experience or Bachelor Degree with eight years technical experience in chemical disciplines
Exceptional written and verbal communication skills including ability to persuasively communicate
Effective interpersonal skills with the ability to work in a team-based setting; flexibility; achievement-oriented with appropriate concern for quality are
Computer literacy required
In addition to above: Record of achievement of regulatory approvals and demonstrated success in working with regulatory authorities and/or toll manufacturers
In depth knowledge of U.S. and European Regulatory and pharmaceutical issues
CMC support of new pharmaceutical and/or marketed pharmaceutical products worldwide
Extensive customer interactions with R&D functions, QA, Manufacturing and other teams within Regulatory Affairs
External influence in trade organization or regulatory professional societies

Senior Manager, Regulatory Affairs Resume Examples & Samples

Minimum 5+ years’ pharmaceutical/biotechnology industry experience, 2 years regulatory experience
Demonstrate excellent communication skills
Ability to represent the department on project teams
Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload
Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
Demonstrate effective cross-cultural awareness and capabilities
Some direct experience in interfacing with relevant regulatory authorities
Good knowledge and understanding of applicable regulations

Senior Manager Regulatory Affairs Resume Examples & Samples

Proficient in MS Word, Excel, PowerPoint, MS Project, Liquent, and Trackwise
Excellent organizational and communication (written and verbal) skills
Demonstrated ability to work successfully on project teams
RAC certification preferred
Previous experience working in a fast paced environment on multiple product lines
Manufacturing, QA/QC experience, regulatory strategy development experience

Senior Manager Regulatory Affairs CMC Resume Examples & Samples

Leads, implements and drives regional and/or global CMC strategy & submission activities, including planning, writing, review, coordination and submission of CMC sections of Briefing Packages, meeting requests, INDs, NDAs/ BLAs, CTAs, MAAs and other regulatory filings for assigned development projects and marketed products
Interfaces with Health Authority project managers and CMC reviewers to facilitate approval of regulatory submissions and coordinates responses to Health Authorities with appropriate Teva personnel and departments to resolve outstanding regulatory issues
Arranges for, coordinates and leads teams in planning, preparation, and execution (lead facilitator) of meetings or teleconferences with Health Authorities (e.g., FDA, EMA)
Represents regulatory CMC and provides US regulatory filing strategy recommendations to interdisciplinary project teams. Coordinates global regulatory strategy development with relevant groups to ensure consensus on critical issues, and identification and communication of regional differences including implementation plans
Bachelor’s Degree in scientific field, such as biology, biochemistry, biotechnology, cell biology or equivalent, PharmD, Ph.D., or Master’s degree preferred
7 years (or equivalent combination of education and related work experience) of biopharmaceutical industry experience in new drug regulated product strategy and submissions; including working knowledge of U.S. laws, FDA regulations and guidance applicable to registration and approval of drugs or biologics
Working knowledge/experience in regulatory submissions and approval processes for biopharmaceuticals and ability to deal with complex CMC regulatory issues and requirements
At least 7 years in regulatory affairs with proven experience in successful filing and defense of major submissions -- IND / NDA / BLA / CTA / MAA
Strong background in biopharmaceutical development with focus on CMC aspects
Experience implementing principles embodied in ICH Guidances Q8, 9, 10, including QbD
2-4 years project management experience
Exposure to biosimilar development
Working knowledge of relevant drug and biologic laws regulations and guidances / guidelines
GCPs, GMPs, GLPs
RAC

Senior Manager, Regulatory Affairs Resume Examples & Samples

Provides review of materials for medical, nutritional and biochemistry-based accuracy and substantiation of all claims
Regulatory and medical reviewer for all labeling materials created for nonprescription products, such as OTC drug products, dietary/nutritional supplements, foods, and/or cosmetics which MCH commercializes through retail, professional, and e-commerce chains
Serve as the regulatory and medical reviewer for all advertising and promotional materials created for nonprescription products, such as over-the-counter (OTC) drug products, dietary/nutritional supplements, foods, and/or cosmetics which MCH commercializes through retail, professional, and e-commerce chains
Provides review of materials for adherence to applicable regulations and guidance documents and for other regulatory requirements
Provide nutritional and biochemistry-based technical support for all Consumer Healthcare products
Provides general regulatory affairs support for MCH
Manages the filings and applications with the FDA and other government agencies, submission of required reports to the agency, Pharmacovigilance support, etc
Strategic regulatory and scientific technical support in terms of new product opportunities, dietary supplement research and development, due diligence, product launch, etc
Bachelor’s degree or equivalent in a scientific field of study and 4-7 years of experience are required. Master’s degree preferred. Related experience may also be considered
Knowledgeable in FDA regulations as pertaining to dietary supplements (foods), OTC drugs, and cosmetics
Must have excellent collaboration, influencing and negotiation skills, and be able to establish and maintain collaborative working relationships with intra-department, inter-department, and external third party personnel
Ensures timely submission of appropriate regulatory documents
Must be able to work in a fast paced environment with demonstrated ability to manage multiple competing tasks and demands
Knowledgeable in Health Canada regulations as pertaining to drugs and natural health products
Some physical demand. Often lifts light-weight material up to 20 lbs. May involve walking, standing, carrying, pushing, and/or pulling
Proficiency in speaking, comprehending, reading and writing English is required

Senior Manager Regulatory Affairs Resume Examples & Samples

Act as the process owner of Global Regulatory Council (GRC), Product Labeling Council (PLC), Pre-Market Notification (PMN) and Global Product Registration System (GPRS). Continuously improve the processes and update the relevant SOP or Procedures
Provide direction regarding pre-market regulatory policy and practices for all operations ensuring the development and implementation of advanced and aggressive regulatory strategies that provide a competitive edge to Beckman Coulter
Understanding BEC products and technologies and current processes of product development and product submission registration among all product lines. Ability to process mapping the registration process and standardize it with a best practice for all product registrations
Ensure business teams consider the impact of current or emerging regulatory issues, works with management from all sites to facilitate and ensure company practices are consistent with the corporate regulatory risk posture
Communicate with regulatory agencies in the US, Canada, the EU and other geographic areas, as required
Work with appropriate functional management to address labeling discrepancy issues in a timely fashion
Lead the global product registration team in tracking and managing Global Product Registration System (GPRS) for needed updates or upgrade
Be responsible for monitoring, tracking and updating the global product registration database for the needed visibility and managing regulatory compliance risks
Communicates and reports regularly to executive management, users and staff on the status of the quality system
Utilize Danaher Business System (DBS) tools to drive compliance and effective processes
Assure that there are no significant interruptions to the business due to quality or compliance issues
Develops resourcing strategies, allocates budgets, staff, tools and specialized support necessary for efficient operations
Subject matter expertise in regulatory affairs for medical devices
Demonstrated knowledge and understanding of regulations and guidelines governing the areas of medical devise and diagnostic development
Experience in the, registration and commercialization of medical device and diagnostic products
Ability to develop effective regulatory strategies and apply regulations to pre-market and post-market strategies
Possess a broad knowledge of surrounding area including Quality Assurance, Manufacturing and Development
An established personal relationship with the FDA and experience with IVD products
Multi-tasking with flexible working hours to cover various time zones globally
Proven leadership and managerial skills in order to build and sustain a vision for the work group
Demonstrated track record of developing organizational capability
On-Time Deliverables are critical to this position
Critical thinker able to address complex situations and issues
Express abstract and controversial ideas clearly and effectively; ensure communications, key decisions and strategies are understood in all settings
Acts decisively, holds position and challenges others appropriately
Develop strategic goals and objectives from knowledge base and understanding of a customer’s business
Manage changing conditions, processes and approaches; lead organizations through change effectively

Senior Manager, Regulatory Affairs Resume Examples & Samples

Preparing and assisting in the preparation of high quality Latin-America and US submissions
Liaise proactively with internal cross-functional teams as well as external partners supporting development activities
Identify potential regulatory risks and propose options to mitigate risks
Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents
Assume assigned responsibilities for routine and non-routine contact with health authorities including coordinating and managing health authority meetings
Maintain awareness of competitors’ activities and share potential impact these activities may have on the product development program
Delivers project assignments supporting the business e.g. representation on functional work streams
Assist in development of regulatory standards and SOPs
Assist in due diligence activities for in-licensing opportunities
Bachelor’s degree in Science or related discipline
5+ years pharmaceutical experience
Flexibility and adaptability - Decides what to do based on the situation. Changes behavior or approach to fit the situation or the person. Works effectively in ambiguous situations
Communication skills – knows when and how to communicate, using strong interpersonal skills and written communications when appropriate
Results focused – ability to overcome obstacles and achieve key outcomes
Analytical – logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions
Organizational Skills -
Integrity – overriding commitment to integrity and high standards in self and others
Build effective partnerships – identifies opportunities and takes actions to build effective relationships within team and with other areas
Influencing skills - through well thought through rationale and effective communication skills, able to influence key decisions

Senior Manager Regulatory Affairs & Project Mgmt Resume Examples & Samples

Function as the Global Process Owner (GPO) for global regulations and Global Regulatory Council (GRC). Maintain and improve the process; chair scheduled meetings, track the progress of major projects, and update the SOP accordingly
Collaborates across the organization at all levels, across functional groups and geographic locations, including executive management; manage matrices effectively
Liaise with the regional and geographical Q&RA organization to support and ensure alignment with BEC global policies and procedures
Maintain current knowledge of FDA and international regulations, guidance documents and standards applicable to company products
Participate in research of regulatory issues and dissemination of regulatory information to the various departments and senior management as required
Works with minimal guidance and expands knowledge and skill sets beyond own area
Supervise Regulatory Affairs associate and/or interns as required
Utilize Danaher Business System (DBS) tools to drive compliance and effective processes; developing regulatory metrics and scorecards and institute data-based process improvements which will align with corporate and business unit goals
Assure that there are no significant interruptions to the business due to compliance issues
A Bachelor’s degree with 14+ years of experience, Master’s degree with 12+ years of experience, AND at least 4+ years managing people
Professional designations are not required but training and certificates in quality or Regulatory Affairs are desired. (e.g. CQE, CQA, RAC, Six Sigma, Lean Principles)
Project Management experience and a proven track record for driving completion required
Comprehensive understanding of reagent manufacturing processes and principles
Subject matter expertise in Regulatory Affairs for medical devices or in vitro diagnostics
Demonstrated knowledge and understanding of Global regulations and guidelines governing the areas of medical devices or in vitro diagnostics
Experience in registration and commercialization of medical device or diagnostic products. Must have a hands-on experienced in both pre-market product registrations and post-market surveillance program in the IVD industry
Possess a broad knowledge of other functional areas including Quality Assurance, Manufacturing and Development
Demonstrated track record of developing organizational understanding and capability as it applies to Regulatory Affairs
Global experience leading and/or participating on cross functional teams
Must possess excellent communication (both written and verbal), influential and negotiating skills, allowing the effective communication of complex regulatory information to a wide variety of audiences and leveraging for the best outcome
Critical thinker able to address complex situations and issues.Must be a strong collaborative facilitator and leader, building consensus while championing global regulatory compliance
Capable of multi-tasking, on-time delivery, and applying the learned knowledge effectively
Manage changing conditions, processes and approaches
Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals

Regulatory Regional Senior Manager Regulatory Affairs Resume Examples & Samples

Seven to 10 years of regulatory experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience
Extensive experience with drug development and strong working experience with CBER requirements
Experience managing projects from early development through BLA approval with a strong biological business orientation
Demonstrated working knowledge of regulatory guidelines and legislative requirements for regional regulatory authorities
In-depth knowledge of GMP, GCP and GLP
Demonstrated ability to deal with rapid change
Demonstrated sound judgment and flexible approach to managing situations

Senior Manager, Regulatory Affairs Resume Examples & Samples

6+ years significant experience in regulatory affairs, or appropriate relevant experience
Requires scientific and regulatory knowledge pertinent to development aspects, particularly CMC
Operational knowledge of IND and BLA regulations and experience in US regulations pertinent to CMC product development, preferably vaccines/biological
Experience in liaison with major regulatory Agencies, preferably FDA
Demonstrated knowledge in regulatory affairs and drug/vaccine development or equivalent
Ph.D; Pharmacy, Chemistry, Biology or Medicine
Experience in providing strategic advice on integrated regulatory development plans, and problem solving in cross-functional teams in drug/vaccine development
Ability to assess and determine regulatory strategy for reporting of postapproval CMC changes
Strategic thinker – ability to provide input into regulatory strategy and evaluate potential impact on overall project/product strategy
Good influencing skills
Enterprise thinking – needs to and the potential impact on RA, including how RA may facilitate in achieving the overall goal
In collaboration with the function and regions, ensure rigorous scientific content/quality/compliance of documents intended for regulatory submissions

Senior Manager, Regulatory Affairs Resume Examples & Samples

Represent regulatory affairs on product development and commercialization teams related to Transcatheter Mitral and Tricuspid Therapies
Interacts with FDA and/or other regulatory bodies for submissions and projects
Will monitor proposed and current US and EU regulations and guidance, and will advise the impact of such regulations and guidance on the company within the scope of assigned
Responsible for regulatory review for claims support of promotional material, labeling content, product and process changes, and product documentation
Able to collaborate and take direction from team leaders, while working with RA management on RA strategy for US IDE, US PMA, CE Trial, CE Mark, as required
Prepares document packages for submission to global regulatory agencies (IDEs, PMAs, annual reports, 510(k)s and CE marking design dossiers and technical files). Prepare IDE and PMA annual reports and Justifications to File
Assume regulatory review of promotional material, labeling content, product and process changes and product documentation
Work on multiple projects where analysis of situations or data requires an evaluation of intangible variables
May work on new/emerging technology that has no or limited history
Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
Requires a minimum of twelve years’ experience in Regulatory Affairs. Medical device experience in other areas, may be considered
Experience in preparing domestic FDA and EU product submissions required
A Bachelor’s degree is required, preferably in a scientific discipline
Demonstrated competence in working as part of a focused, project team
Demonstrated understanding of basic regulatory requirements for promotional materials
Requires familiarity with new product development systems; a strong working knowledge of all U.S. regulations that affect
Class II and Class III devices; a strong understanding of global regulations; excellent writing and verbal communication skills; and strong problem-solving and analytical ability

Senior Manager, Regulatory Affairs, CMC Resume Examples & Samples

Experience and knowledge in general Medical Devices essential
Experience and knowledge of classification of medical devices, including borderline products and SaMD a distinct advantage
Experience and knowledge in Digital/e-Health products, In-Vitro Diagnostics, Combination drug delivery devices and use of devices in Pharmacological Clinical Investigations highly desirable
Experience in interfacing with relevant global regulatory authorities and Notified Bodies essential
Experience and knowledge in the preparation of global regulatory submissions is essential
Knowledge and understanding of current and future applicable global regulations essential, especially MDR/IVDR
Experience of managing medical device and combination device/drug post market surveillance/vigilance issues is essential
Familiarity with medical device cGMP systems such as ISO13485 highly desirable

Senior Manager, Regulatory Affairs Resume Examples & Samples

Provides regulatory review and oversight for product-related changes to three biomaterials manufacturing facilities, supporting PMA, 510(k) and CE Class III medical devices
Develops the regulatory strategy and reviews all design transfer activities related to tissue-based New Product Introductions
Actively participates in New Product Introductions and Design Control activities for select tissue technology products
Authors PMA and design dossier regulatory submissions related to new manufacturing and manufacturing changes
Collaborates and assists in international registrations
Coordinates roll-outs of product changes with corporate and international regulatory teams
Responsible for maintaining regulatory approvals and lifecycle management for select tissue technology products
Works in partnership with Manufacturing and QA/QC to ensure overall regulatory compliance
Initiates regulatory reviews and input for CAPAs, investigations, and health hazard evaluations related to regenerative tissue technology products
Minimum of 10 years regulatory experience with increasing responsibility in the medical device industry, and 3 years previous management experience (or equivalent)
Must have proven ability to prepare and submit documents to FDA, such as 510(k) Premarket Notifications, Investigational Device Exemptions (IDEs), and/or Premarket Approval Applications, (PMAs), Investigational New Drug (IND), or New Drug Applications (NDA)
Experience in working with cross-functional teams; especially with manufacturing sites
Experience with tissue products, including collagen products, is preferred
Must possess and demonstrate an excellent understanding of requirements specifically related to Class 3 medical devices: FDA requirements, ISO Standards, requirements of the Medical Device Directive (93/42EEC) and other international requirements
Experience in interacting with FDA and Notified Bodies

Senior Manager, Regulatory Affairs Resume Examples & Samples

Obtain updated information on changes to applicable regulations and standards to ensure continuing compliance. Present major regulatory issues or changes to applicable regulations and standards to management & executive staff with recommended actions as required
Manage process to maintain all applicable federal Facility Registrations and Listings, and State Licenses
Manage interface with regulatory agencies and certifying bodies for site inspections, presentations, and submissions, as well as matters regarding compliance with quality system requirements, and product problems

Senior Manager Regulatory Affairs Resume Examples & Samples

Represent Regulatory Affairs on interdepartmental teams for projects with Operations, Development, QA, Marketing, and other functions as required
Manages IVD product strategies for submissions, registrations, and maintenance globally
Prepare regulatory submissions for US (e.g. 510k, PMA) and Health Canada (e.g. Class III) approvals for QIAGEN IVD products including reagents and instrumentation/software
Prepare technical documentation needed to demonstrate compliance with applicable European Directives
Interface with Regulatory Agencies for inquiries/issues and provide support in customer facing issues
Represent Regulatory Affairs during management of the IVD product change process

Senior Manager, Regulatory Affairs Resume Examples & Samples

Bachelor’s Degree with a major in an analytical field of study from an accredited college or university is required; advanced degree is preferred
Minimum 5 years of relevant experience in Regulatory Affairs with pharmaceutical or biological products
Demonstrated strong understanding of regulatory requirements in the US, particularly with respect to advertising, promotion, and other publicly communicated materials as well as product labeling; ability to interpret and apply the regulations to specific Company projects
Excellent written and oral English communication skills
Proven attention to detail, while at the same time seeing the big strategic picture
Demonstrated strong organizational skills with ability to set priorities and meet deadlines, as well as to respond to changing deadlines and priorities
Demonstrated negotiation and problem-solving skills
Ability to work well independently with minimal supervision
Sound working knowledge of writing and publishing computer applications
Proven ability to communicate well with colleagues across multiple disciplines in the organization

Senior Manager, Regulatory Affairs Resume Examples & Samples

Develop and execute global regulatory labeling strategies and plans for complex projects including new products and ongoing global compliance for products already on market. Understand and incorporate key labeling requirements and best practices into global labeling strategies
Drive regulatory promotional strategies for the review, approval, and submission (as needed) of advertising and promotional materials across products and product types. Evaluate technical and scientific information in support of product claims
Formulate and drive global UDI initiatives as well as global labeling traceability requirements within project and product teams
Represent or lead the RA labeling function on assigned cross-functional project teams and projects. Represent Baxter in relevant external industry workgroups, as needed. Contribute independent ideas and help guide the overall effectiveness of the cross-functional labeling team
Develop and maintain effective cross-functional partnerships and network within RA and key stakeholders including Marketing, R&D, QA, Supply Chain to drive key global labeling strategies and initiatives
May provide matrix or project related supervision of individuals
Ability to manage complex projects and timelines in a matrix team environment. -Strong project management and organizational skills
Bachelor’s degree or country equivalent with 5+years of regulatory experience and 8+ years of related professional experience in related field(s), including managing people or projects
Direct experience with global device labeling will be an advantage

Senior Manager Regulatory Affairs Resume Examples & Samples

To act as system authority, advising CN departments on legislation, rules and regulations affecting Operations and how best to manage compliance to protecting company’s financial and operating interests. Ensure HQ departments and field regulatory officers are kept informed of latest regulatory requirements and how they will impact upon operations. Assess the related corporate impacts of proposed initiatives or activities
Within the framework of Canadian and US Federal regulatory acts, represent CN in discussions and working groups with regulators and railway industry to develop and advance new regulations or carry out modifications to existing regulations which best ensure that CN’s interests are protected. Lobby regulatory agencies for change that benefits the railway. Develop and file applications for exemptions to rules and standards
Oversee response to requests for data or information from various regulatory agencies including CN comments on TSB draft accident reports and Transport Canada system safety audits
Manage CN’s handling of Transport Canada Rail Safety S31 Notices and Orders and HRSDC Directions including ensuring response by deadlines
Ensure accuracy of reporting of accidents and incidents to the Transportation Safety Board including monthly and annual reconciliation of CN and TSB numbers
Work with CN Law department to develop CN strategy for negotiated cost sharing negotiations involving grade separations, road and utility crossings and fencing. Prepare technical and legal arguments to support CN’s position in legal cost apportionment disputes administered by Canadian Transportation Agency
University degree in fields such as business management, public affairs, and government affairs is preferred. (terminology maybe different in the US)
3 to 5 years Railroading experience
Excellent Microsoft tools knowledge (ex. Excel, Word)
Thorough knowledge of CN network and operations as well as Canadian and US regulatory acts, general orders, regulations, rules, guidelines, internal policies and processes concerning CN network and operations
The ability to juggle multiple projects and meet deadlines, as well as strong analytical, organizational and process management skills and problem solving abilities needed
Sound negotiating skills and proficiency in risk analysis
Ability to establish and maintain good working relationships with both internal clients and regulatory agencies, to organize and conduct effective meetings and make presentations to a variety of audiences
Initiative, sound judgement and willingness to accept responsibility with a minimum of direction

Senior Manager Regulatory Affairs Category Resume Examples & Samples

Acts as a Business Partner and provides regulatory advice across sub-Category/significant portfolio on all aspects of drug/cosmetic/devices/foods and supplements (dependent on category) development and regulatory requirements, both current and future
Provides regulatory direction for a sub-category/significant portfolio of products. Develops novel regulatory strategies and influences approaches in order to secure competitive approvals and speed to market in conjunction with LOC regulatory teams
Communicates influences and negotiates effectively with cross-functional internal and external groups at all levels
May lead an efficient and well motivated small team; including effective people development
Ensure appropriate prioritization and resourcing of projects and delivery of high quality regulatory files to agreed timelines
Leads non-product related activities, both in the function and cross functionally, in order to direct new policy or pioneer new processes or improvements to GSK's competitive advantage
Influence the external regulatory environment through networking with key individuals, identifying opportunities and influencing guidelines. May act as GSK representative to external groups for specific topics (e.g. AESGP, Cosmetics Europe)
Support the development of the strongest claims possible aligned to consumer insight and within the regulations, ensuring risks are appropriately addressed and communicated within Copy Review Committee
In conjunction with the category regulatory CMC lead, ensure support for the full life cycle of products, including: maintenance activities; Design to Value, complexity reduction, value engineering initiatives; change controls, etc with supply chain and technical excellence Oversees compliance in all actions by ensuring global, regional and local processes, policies, SOPs and working instructions are adhered to

Senior Manager, Regulatory Affairs CMC Resume Examples & Samples

Regulatory coverage and oversight in all CMC submissions (including clinical trial, marketing and post-marketing applications, routine reports/renewals) and ensure that submissions comply with applicable global regulatory requirements as well as company policies and procedures, with the goal of obtaining the earliest possible product approvals
Maintain up-to-date knowledge of regional and global regulatory CMC requirements, analyze current trends and anticipate changes in the Regulatory requirements to adjust CMC strategic plans accordingly
Write and review technical documents for submissions and recommend changes as appropriate to ensure approval and/or compliance with existing regulatory approvals
Provide regulatory assessments of manufacturing changes within the change control system and filing strategy guidance to Technical Operations and Quality department, including supporting preparation for facility inspections of vendor sites by health authorities when necessary
Contribute to the development and implementation of short and long-term regulatory strategies for assigned projects and programs
Manage relationships with key stakeholders in technical Operations and Quality and across Regulatory Affairs to provide CMC regulatory support in achieving strategic objectives
Work effectively with Regulatory colleagues and stakeholders in addressing GMP issues
Create and maintain Regulatory CMC development plans that are aligned with product development plans
Initiate local process improvement and contribute to local and/or global process improvements which have significant impact for the Regulatory Affairs Department or other departments
The position is responsible for handling multiple projects with competing priorities. May involve up to 10% travel
BS in relevant scientific discipline
Minimum of 5 years of experience in Regulatory CMC in pharmaceutical industry
An advanced degree in relevant scientific discipline is desirable, certification in Regulatory Affairs is a plus
Previous experience working in a fast paced environment on multiple product lines a plus
Solid understanding of FDA regulations and GMPs requirements on drugs and devices in both development and commercial stage products
Good expertise on Regulatory CMC, exposure to international Regulatory CMC is a plus
Experience in regulatory assessments of post-marketing manufacturing changes and in preparing technical portion of INDs, NDAs, amendments and supplements
Strong organizational and program management skills to maintain high level productivity, innovation and priority setting, completing assignments on time and on budget
Strong problem solving and diplomacy skills required
Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company

Senior Manager, Regulatory Affairs Resume Examples & Samples

Represent regulatory affairs on product development and commercialization teams related to transcatheter mitral valve replacement programs
Additional Responsibilities will include
Exercise independent judgement in determining appropriate regulatory action and requirements for new product or product changes and preparation of regulatory documents
Exercise judgement within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
Ability to travel 25 %

Senior Manager, Regulatory Affairs Resume Examples & Samples

Prepare and manage annual budgets
Assist in regulatory due diligence and acquisition transfer activities
Manage and execute pre-approval compliance activities
Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
Monitor and submit applicable reports and responses to regulatory authorities
Ensure compliance with product post-marketing approval requirements
Provide training for stakeholders on current and new regulatory requirements to ensure company-wide compliance
Communicate regulatory agency/industry positions to internal stakeholders
Conduct technical meetings with regulatory advisory committees and government agencies
Support and lead assigned improvement activities
Notify, consult or brief legal counsel when appropriate
Must have demonstrated extensive working knowledge of the U.S.A. Federal Regulations for medical devices including those applicable to the import/export of devices
Working knowledge of statistics and electronic documentation and information systems
Advanced Degrees preferred
Advanced regulatory affairs training – MS, RAC or other professional certification

Senior Manager, Regulatory Affairs Global CMC Resume Examples & Samples

Planning and co-ordination of the writing and reviewing for Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents)
Participate and support as an active member of a multi-disciplinary team to establish Regulatory CMC strategies for commercial products, late and early stage development programs, under the supervision of GRA-CMC leadership
Through the performance of risk assessments, work with GRA-CMC leadership to identify and communicate potential risks associated with strategy scenarios to the a multi-disciplinary team
Coordinate the preparation and timely submission of responses to regulatory agencies. Manage timelines to ensure approvals are timely and development objectives are met
Act as regulatory CMC representative at meetings with business partners and regulatory agencies for CMC related issues
Monitor Global CMC regulations, and assess any changes to ensure all development activities are in compliance with applicable current regulations and guidelines
Ensure continued regulatory compliance of products though adherence to the change control procedures and completion of regulatory impact assessments for assigned commercial products
Verify electronic publishing of regulatory submissions
Identify & support continuous improvement opportunities for the GRA-CMC team and the broader GRA team
Ensure compliance with company policies, procedures and training expectations
Solid working knowledge of CMC regulatory and ability to generate clear, well-argued positions
Must have experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs)
Demonstrated understanding of FDA, EMA and ICH guidelines
BSc/BA with a minimum of five years of regulatory CMC experience

Senior Manager Regulatory Affairs Resume Examples & Samples

Define and execute RA strategies for Europe for pre-approval and post-approval clinical studies and EU commercialization
Provide subject matter expertise and/or leadership to TMTT RA organization on European Regulatory requirements
Deliver project/change management expertise, strategic planning, and implementation support for key TMTT RA organizational initiative
Drive continuous improvement & innovation agenda within the TMTT EU RA function
Responsible for following regulatory activities on European basis and advising the relevant Edwards stakeholders
Management of registration files submission to National Competent Authorities
Participation in different European TMTT Projects providing RA expertise and leadership
Local management of ‘product holds’ and field corrective actions
RA coordination of new TMTT product launches
Advanced Degree or country equivalent in science-related field. Higher degree/PhD will be an advantage
Minimum 10+ years in medical device and pharmaceutical industry with increasing levels of expertise/experience
Established understanding of registration processes and their inter-dependencies and a demonstrable track record of driving regulatory strategic and operational excellence
Expert knowledge of regulations, current industry practices, and strong experience with interpretation and application of regulatory guidelines pertinent to a diverse drug/device portfolio
Established credibility with regulatory authorities and other external stakeholders and understanding and translation of regulatory trends into actionable opportunities
Required language skills: German, English, additional language a plus

Senior Manager, Regulatory Affairs Operations Resume Examples & Samples

Participate in the Regulatory Operations Submissions Management Team for Branded Products
Ensure all publishing and submissions are undertaken effectively in compliance with timeline requirements
Assist in developing strategy for use of electronic document management software (EDMS) within Regulatory and all applicable departments, direct administration of the EDMS, address user requirements and upgrades for the system. Serve as primary point-of-contact
Work with Manager, Publishing Group to provide timelines to Project Teams/Regulatory contact regarding submission timelines
Maintain current working knowledge of FDA and other global regulatory requirements
Work with vendors and various departments on multiple software projects, including new installation and upgrades, serving as a point-of-contact
Participate in project team meetings updating status of Regulatory Operations activities, represent the company’s Regulatory Operations group in internal and external development project meetings and contribute to the establishment of regulatory strategies for new products and processes
Assist in managing expenditures related to approved contracts
Display leadership to staff internal and external to the department
Assist in providing regulatory advice and interpretation of submission regulations and guidance to Regulatory Affairs staff and team members
Develop and implement SOPs and/or work instructions
At least 5 years of experience in Regulatory Affairs, with at least 2 years of experience in Regulatory Operations
Managerial experience preferred
Knowledge of IT systems and electronic submission requirements and processes for FDA and other global health agencies, for pharmaceuticals, biologics, and medical devices
Detailed oriented with a high degree of organizational skills and be able to handle confidential materials. Very strong focus on highest quality
Possess very strong PC computer skills
Able to accomplish work independently and as part of a team
Able to set and meet deadlines
Able to take a project from start to finish while working in a constantly changing environment
Handle routine details and unexpected changes without losing focus on projects; determine task priority and ensure deadlines are met
Team player as demonstrated by good communication/collaboration skills
Strong interpersonal skills, including the ability to remain calm, professional, diplomatic, and positive
Exercise confidentiality
Positive attitude and ability to establish and maintain positive working relationships

Senior Manager Regulatory Affairs Resume Examples & Samples

Responsible for providing the regulatory considerations and strategies for product prototype development, proof-of-concept activities, partnership options and vendor due diligence
Develop, implement, communicate, and maintain regional regulatory plans for TDI/DH (Technology Innovation/Digital Health) initiatives/ projects
Perform device determinations for TDI/DH programs as needed
Provide support with review of external communications with hospitals, clinics and academic innovation centers as well as contracts, terms and conditions from a regulatory perspective
Support TDI/DH technology & software development (including co-development and supplier management) efforts by providing regulatory guidance
Deliver ongoing device education and training to TDI/DH colleagues pertaining to innovation
Assist in training Amgen Affiliates with respect to regulatory requirements of developing TDI/DH products
Facilitate communication of changes in Regulations, Standards, and Policy which are likely to impact TDI/DH activities
Represent the EU Tech Hub/Amgen at external events
Responsible for developing and maintaining an overall EU process map to bring digital products to market
Collaborate with Device Regulatory International personnel who perform EU based (legal manufacturer) registrations
Help identify responsible quality contact as needed for project specific needs as well as help identify responsible legal contact as needed
5+ years experience in EU device regulatory matters
Some regulatory experience in drug regulatory matters
Multi-sectoral awareness/exposure a bonus
Regulatory Device and Design Control experience
Software development in the healthcare sector
Experience working in cross-functional matrix organization

Senior Manager, Regulatory Affairs Resume Examples & Samples

Representing the region
Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
Regulatory knowledge in national regulations
Experience with national legislation and regulations relating to medicinal products
Understanding of the registration procedures in region for MA, post approval changes, extensions and renewals
Understanding of drug development

Senior Manager, Regulatory Affairs Resume Examples & Samples

In support of Merial strategic objectives and in alignment with Business Operations, Industrial Operations, CMC, and R&D, responsible for the defense and maintenance of FDA-approved products
Ensure compliance of pharmaceutical products throughout the lifecycle in close collaboration with Business Operations, R&D, CMC, Quality Assurance, and other departments as appropriate
Provide regulatory assessments for proposed business and manufacturing changes related to approved pharmaceutical products in compliance with FDA guidelines
Define U.S. Regulatory filing strategies of assigned projects regarding approved products and assigned development projects This includes coordinating activities and defining timing of submission and approval in order to have regulatory agreement, as required, before implementation
Prepare regulatory submissions for post-approval activities related to FDA-approved products as well as assigned development projects
Prepare labels, package inserts, etc. based on applicable regulations and approved platform label, in cooperation with Business Operations and Supply Chain
Serves as regulatory liaison for assigned projects
Define regulatory requirements for projects, as assigned, for incorporation into Development Plans for pharmaceutical projects. Set working priorities within the team and communicate them routinely
Serve as a member of interdepartmental project/core teams providing regulatory expertise for assigned projects during the development, registration, and post-approval extension phases of a project
Principle contact point for Business Operations, R&D, and Industrial Operations regarding change control (ILPM) and strategic issues related to FDA-approved products
Promote functional excellence with the goal to foster innovation, optimize time-to-market and reduce project and portfolio risks
Serves as a member of interdepartmental working groups providing regulatory expertise for assigned projects or segments of projects related to the supplements or maintenance of approved products
Provide technical regulatory support to the RA International team for assigned products
Maintains an awareness of regulatory issues and current possible developments in assigned areas
Participate in trade association activities as assigned

Senior Manager Regulatory Affairs Resume Examples & Samples

Prepare US (510{k), PMA, IDE) submissions and technical files
Review and approve labeling and promotional materials
Develop and recommend regulatory strategies
Assist in the review and policies and procedures
Interact with the FDA and other regulatory agencies
Provide coaching to regulatory specialists

Senior Manager, Regulatory Affairs, CMC Resume Examples & Samples

Author regulatory content, provide regulatory CMC content guidance, and review all regulatory CMC submissions (Module 3, Module 2.3 and Module 1) such as IND amendments, Meeting Requests/Meeting Packages, NDA, sNDA, MAA and Variations, as needed, for conformance with established requirements
Ensures CMC project team colleagues and key stakeholders are apprised of risks that may impact CMC regulatory success, exercising sound judgments and communicating in a professional and timely manner
Evaluates change controls for regulatory impact and filing requirements
Conduct CMC regulatory due diligence reviews for potential new product opportunities
Grow corporate, project and industry knowledge. Analyze and communicate current CMC Regulatory guidance and regulations, as well as industry and regulatory agency best practices and trend to senior management and other departmental personnel

Senior Manager Regulatory Affairs, DEA Resume Examples & Samples

Establish and lead DEA inspection team, ensure related activities such as the inspection preparation room are managed effectively and efficiently, appropriately delegate inspection related activities to direct reports or partner department staff
Ensure staff involved with DEA inspections are trained and records retained appropriately
Manage daily activities related to the DEA Corporate Compliance Program and State Licensing compliance such as, but not limited to, theft/loss investigations and reporting, suspicious order monitoring, import/export records, and quotas
Monitor regulatory environment related to DEA and State Licensing directly, with assistance from direct reports, and consultants
Contact DEA or outside consultants to resolve regulatory issues and negotiate directly as required
Ensure regulatory files and data systems are maintained in compliance with internal SOPs
Represent regulatory affairs in project meetings and provide regulatory commitments as required
Communicate and collaborate with senior management in all areas of the company
Support a continuous improvement environment and develop staff to execute continuous improvement projects
Provide oversight for RA processes and systems
Hire, train, coach/mentor and evaluate performance of direct reports
Assign, balance and prioritize workloads of direct reports
Ensure quality of all agency submissions and communications
Projects as assigned by management
Supervises non-exempt and/or exempt direct reports
Must possess advanced analytical skills and the ability to identify and apply DEA and State Licensing policies and general regulations to specific products or projects and create new policies as required
Ability to monitor, analyze, raise awareness, and assess impact of regulatory issues for stakeholders inside and outside of Regulatory Affairs
Advanced verbal and written presentation and communication skills are necessary
The ability to effectively lead project teams is required
Advanced knowledge of scientific, regulatory, DEA, State Licensing and legal terminology is necessary
These skills are normally acquired through possession of a Bachelor Degree in a health sciences field such as biochemistry, chemistry, pharmacy, pharmacology, or nutrition or food sciences combined with 8-10 years of experience in the health care or pharmaceutical industry and 7+ years of hands on experience in DEA and State Licensing activities
7 or more years of experience in direct supervision

Senior Manager Regulatory Affairs Resume Examples & Samples

University Degree (Bachelor of Science or equivalent scientific discipline)
Minimum of 8 years of experience in regulatory affairs, preferably in industry with some focus on natural health products
Strong Knowledge of Canadian Regulations
Team player who thrives in a fast-paced environment with proven ability to manage multiple priorities
Experience in leadership management an asset
Foresees and clearly communicates potential problems/risks and offers creative, workable solutions
English advanced level, both oral and written. French and/or Mandarin a strong asset
Strategic thinker adept at working cross-functionally to achieve goals in a timely manner
Effective in an environment requiring independent initiative with multiple deadlines and changing priorities

Download Senior Manager, Regulatory Affairs Resume Sample as Image file

Related Job Titles

Manager, Regulatory Compliance Resume Sample

Senior Manager, Community Resume Sample

Senior Manager, Regulatory Compliance Resume Sample

Senior Manager, Regulatory Resume Sample

Associate, Regulatory Affairs Resume Sample

Director, Regulatory Affairs Resume Sample

Manager, Regulatory Resume Sample

Global Regulatory Affairs Resume Sample

Senior Regulatory Affairs Resume Sample

Relationship Manager, Senior Resume Sample

Senior Analyst Regulatory Resume Sample

Community Manager, Community Development Resume Sample

Browse More

Senior Manager, Regulatory Affairs Resume Samples

The Guide To Resume Tailoring

Craft your perfect resume by picking job responsibilities written by professional recruiters

Pick from the thousands of curated job responsibilities used by the leading companies

Tailor your resume & cover letter with wording that best fits for each job you apply

Resume Builder

Resume Builder

15 Senior Manager, Regulatory Affairs resume templates

Read our complete resume writing guides

How to Tailor Your Resume

How to Make a Resume

How to Mention Achievements

Work Experience in Resume

50+ Skills to Put on a Resume

How and Why Put Hobbies

Top 22 Fonts for Your Resume

50 Best Resume Tips

200+ Action Words to Use

Internship Resume

Killer Resume Summary

Write a Resume Objective

What to Put on a Resume

How Long Should a Resume Be

The Best Resume Format

How to List Education

CV vs. Resume: The Difference

Include Contact Information

Resume Format PDF vs Word

How to Write a Student Resume

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager Regulatory Affairs EU Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager Regulatory Affairs Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager Regulatory Affairs Resume Examples & Samples

Senior Manager Regulatory Affairs Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager Regulatory Affairs Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager Regulatory Affairs Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager Regulatory Affairs Resume Examples & Samples

Senior Manager Regulatory Affairs Resume Examples & Samples

Senior Manager Regulatory Affairs Amac Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Manager / Senior Manager Regulatory Affairs Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager, Regulatory Affairs Ad / Promo Resume Examples & Samples

Senior Manager, Regulatory Affairs CMC Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager Regulatory Affairs Resume Examples & Samples

Senior Manager Regulatory Affairs CMC Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager Regulatory Affairs Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager Regulatory Affairs & Project Mgmt Resume Examples & Samples

Regulatory Regional Senior Manager Regulatory Affairs Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager, Regulatory Affairs, CMC Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager Regulatory Affairs Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager Regulatory Affairs Resume Examples & Samples

Senior Manager Regulatory Affairs Category Resume Examples & Samples

Senior Manager, Regulatory Affairs CMC Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager, Regulatory Affairs Global CMC Resume Examples & Samples

Senior Manager Regulatory Affairs Resume Examples & Samples

Senior Manager, Regulatory Affairs Operations Resume Examples & Samples

Senior Manager Regulatory Affairs Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager, Regulatory Affairs Resume Examples & Samples

Senior Manager Regulatory Affairs Resume Examples & Samples

Senior Manager, Regulatory Affairs, CMC Resume Examples & Samples

How to Make
a Resume

50 Best
Resume Tips

200+ Action
Words to Use

Internship
Resume