Regulatory Affairs Project Manager Resume Samples

The Guide To Resume Tailoring

Guide the recruiter to the conclusion that you are the best candidate for the regulatory affairs project manager 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

A Vandervort

Antone

Vandervort

58547 Keeling Radial

Houston

+1 (555) 627 1621

58547 Keeling Radial

Houston

Phone

p +1 (555) 627 1621

Experience Experience

Philadelphia, PA

Regulatory Affairs Project Manager

Philadelphia, PA

Reichel-Purdy

Philadelphia, PA

Regulatory Affairs Project Manager

Identifies, evaluates, plans, performs and implements process improvement initiatives focused on existing regulatory processes
Monitor submission preparation progress and work with subject matter experts to ensure that submission content is provided in a timely fashion
Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
Provides Regulatory leadership to development teams
Develop global regulatory strategies for UDI implementation and maintenance to ensure regulatory effective dates are met and act as a direct liaison with regulatory authorities. This includes maintaining the product label database
3) Prepare and submit PMA, IDE, 510(k) and international product registrations and licensing applications (original submission and subsequent product enhancements.)
Review, analyze and approve technical data generated by Engineering, Manufacturing, Marketing, Quality Assurance or other related departments for filing purposes

Phoenix, AZ

Regulatory Affairs Project Manager

Phoenix, AZ

Hand, Robel and Welch

Phoenix, AZ

Regulatory Affairs Project Manager

Assist in the development of multi country regulatory strategy and update strategy based upon regulatory changes
Create and maintain Regulatory submission timelines, reports, and trackers with general instruction and ensure that they are functional, consistent, and adequately supported
Maintain an active awareness of EU legislation and assess its impact on AbbVie business and R&D programmes jointly with RI. Develop and execute strategies to respond to those. Propose revisions. Ensure application of policies once established
Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
Lead project teams while providing regulatory direction to development project teams; develops and communicates regulatory strategy for new products
Manage and execute preapproval compliance activities
Manages the development of dossiers for registration of products in countries outside the U.S

present

Detroit, MI

Biocides Regulatory Affairs Project Manager

Detroit, MI

Leffler, Hand and Strosin

present

Detroit, MI

Biocides Regulatory Affairs Project Manager

present

Working with project managers to ensure client and regulatory deadlines are met
Strong commitment to safety, including following established Health and Safety protocols
Good working knowledge of relevant software systems (IUCLID and R4PB)
Strong commitment to delivering high quality work that exceeds clients’ expectations
Coordination of projects, including setting up of biocide project, client liaison and on-time delivery of work to clients and meeting regulatory deadlines
Actively involved with the preparation of dossiers and project co-ordination in support of Project Managers
Work closely with clients, representing JSC in client meetings and act as a focal point for selected key clients

Education Education

Bachelor’s Degree in Science

Central Michigan University

Bachelor’s Degree in Science

Skills Skills

Excellent organizational skills and extreme attention to detail
Strong analytical skills are highly desired
Strong technical writing skills are highly desired
Working knowledge of design and licensing basis for nuclear plants is highly desired
Working knowledge of nuclear power plant design and systems is highly desired
Ability to quickly learn, interpret and master complex protocol information
Ability to work effectively in a team environment and build strong working relationships
Pay strong attention to detail
Excellent written and verbal communication skills
Analytical ability & practical approach

Create a Resume in Minutes

15 Regulatory Affairs Project Manager resume templates

Read our complete resume writing guides

Biocides Regulatory Affairs Project Manager Resume Examples & Samples

Provide high quality regulatory support on biocides projects, including project co-ordination, contact with clients, regulatory bodies and to other JSC staff to meet regulatory and business needs
Coordination of projects, including setting up of biocide project, client liaison and on-time delivery of work to clients and meeting regulatory deadlines
Understand client’s desired outcomes and work collaboratively to ensure deliverables meet quality standards
Contribute to the commercial growth of the business through actively participating in the wider business development activities such as client visits, conferences, and expert groups relevant to expert area, as appropriate
Actively involved with the preparation of dossiers and project co-ordination in support of Project Managers
Develop and maintain expertise in biocides and gain awareness of other regulatory areas as required
Work closely with clients, representing JSC in client meetings and act as a focal point for selected key clients
Working with project managers to ensure client and regulatory deadlines are met
Provide client and internal support on BPR and Guidance as required
Maintain and develop expertise in relevant regulatory areas according to the requirements of the business
Assist in the personal development of other members of the JSC team, as appropriate
Undertake other scientific and administrative tasks on occasion, where this benefits the business as a whole
Educated to degree level within Biology, Chemistry or other related disciplines
Knowledge of the EU regulatory process for biocidal products
Practical experience of the preparation and support of biocide dossiers within the EU
Good working knowledge of relevant software systems (IUCLID and R4PB)
Practical understanding on the use and application of biocidal products
Experienced in project management
Strong commitment to delivering high quality work that exceeds clients’ expectations
Strong commitment to safety, including following established Health and Safety protocols
Effective written/verbal communication and organization/analytical skills
Excellent inter-personal skill with the ability to lead project team and passion to help others develop

Regulatory Affairs Project Manager Resume Examples & Samples

Create and maintain Regulatory submission timelines, reports, and trackers with general instruction and ensure that they are functional, consistent, and adequately supported
Coordinate with DevSci Project Managers to ensure program timelines are integrated and accurately reflect cross functional dependencies
Create and maintain program dashboards for teams and management utilizing defined processes and tools
Document project deliverables and track progress
Monitor submission preparation progress and work with subject matter experts to ensure that submission content is provided in a timely fashion
Track post marketing commitments and annual reporting requirements and ensure all deadlines are met
Establish product registration tracking events and schedule regulatory submissions
Support Regulatory Strategy meetings, including scheduling meetings (as needed), facilitating discussions, documenting actions and conducting all necessary follow-up
Support Regulatory Sub-team operations, including facilitation of Sub-team and Strategy meetings (schedule, prepare/distribute documentation and ensure action item follow-up; meeting leadership often required), under the supervision of the Project Manager
Support short and long-term planning activities for project teams

Regulatory Affairs Project Manager Resume Examples & Samples

Develop global regulatory strategies for UDI implementation and maintenance to ensure regulatory effective dates are met and act as a direct liaison with regulatory authorities. This includes maintaining the product label database
Manage and maintain CE Technical Files and product schedules and make appropriate submittals to the EU Representative and Notified Body
Prepare US submissions, including, but not limited to FDA Drug and Device Listings and establishment registration, 510(k) submissions, 513(g) requests
Prepare reports/license applications to state health boards, as required, e.g., controlled substances, suspicious order monitoring, pedigree compliance
Interpret existing or new regulatory requirements as they relate to company products/operations and procedures, clinical studies, testing, records, etc. to ensure ongoing compliance
Provide regulatory guidance and support to project teams including regulatory filing strategies, testing and standards requirements
Review, analyze and approve technical data generated by Engineering, Manufacturing, Marketing, Quality Assurance or other related departments for filing purposes
Review, provide feedback and approve design and manufacturing changes, nonconforming materials reports, test protocols and reports to ensure regulatory compliance with FDA, Health Canada, Medical Device Directive (MDD), ISO 13485 and applicable standards and determine filing or notification requirements
Provide guidance, review and approve promotional and advertising materials, product claims, training materials, Instructions for Use, technique guides, labels and other related labeling to ensure compliance with regulations
Manage post market surveillance activities, i.e., adverse event reporting and field corrective actions
Work closely with Quality Assurance and participate in internal and external audits as well as communicating with regulatory officials, as necessary
Participate in special projects and performs other duties as required
Meeting company standards pertaining to quantity and quality of work performed on an ongoing basis, performing all work related tasks in a manner that is in compliance with all Company policies and procedures including World Wide Business Standards
Perform the position’s duties in a professional manner, supporting Ortho Organizers’ and HF Acquisition Co.’s Quality Policy. Must understand, follow and comply with regulatory requirements as applicable to various processes. An understanding of FDA’s Quality System Regulations (21 CFR 820) and cGMP for drugs (21 CFR 211) and ISO Standards (ISO 13485) is required
Demonstrated ability to lead and manage projects
Ability to effectively problem-solve through critical thinking and root-cause analysis with minimal direction and make decisions with confidence
Excellent organizational skills and extreme attention to detail
Excellent written and verbal communication skills to include interacting with both internal personnel and external organizations (regulatory authorities, customers, distributors, etc.)
Ability to prioritize, multi-task and adapt to change
Ability to work within budget constraints and to work with minimal to no guidance to perform job function
Ability to work effectively in a team environment and build strong working relationships
Ability to read, analyze and interpret common scientific and technical journals, legal documents, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents
Ability to respond in a timely manner to inquiries and complaints from regulatory agencies
High degree of initiative and self-motivation with a strong sense of accountability
Word processing skills, including Microsoft Word, Excel, and PowerPoint

Regulatory Affairs Project Manager Resume Examples & Samples

Participate on product development teams to insure US and EU regulatory requirements are incorporated as part of the development process
Author submissions and other regulatory documents to obtain approval to bring new or modified products to market including but not limited to 510(k)’s, IDE’s, PMA’s, Technical Files, and Design Dossiers
Review and approve labels, labeling and marketing/sales collateral materials for pre and post - market applications
Support marketing, R&D and manufacturing teams in regulatory assessment of proposed changes or product transfers
Address and advise teams on appropriate pathways to market
Interface and coordinate with the FDA, Notified Bodies, Competent Authorities and other regulatory agencies on submissions, approvals or other issues
Establish and maintain regulatory information systems both electronically and hard copy
Interpret existing and/or new regulatory requirements as they relate to company products and procedures
Review and approve change requests with regard to US and EU regulatory requirements
Prepare and update US product listings and EU registrations
Communicate any regulatory body correspondence on submissions to the appropriate team(s) and RA management
Develop, implement and maintain regulatory SOP’s
Conduct quality and regulatory training
510(k), IDE, PMA (original/revision/supplements) preparation experience
Preparation of EU Technical Files and Design Dossiers
Minimum 4-5 years experience in FDA and EU regulated medical device industry
Working knowledge of FDA and EU Medical Device Regulations
Direct interaction with FDA reviewers/inspectors
Direct interaction with Notified Bodies and Competent Authorities
Team based work environment experience preferred
Strong interpersonal, written, oral, communication and organizational skills
Working knowledge of personal computer systems and desktop office applications
Sound understanding of scientific principles
Quality assurance experience a plus

Regulatory Affairs Project Manager Resume Examples & Samples

Gain marketing authorisations for new pharmaceutical products in the UK and Malta where appropriate
Maintain marketing authorisations as required
Gain regulatory authority approval for new clinical trials and amendments to such trials undertaken by AbbVie Ltd in the UK and Malta as appropriate
Liaise with European Regulatory Affairs and Corporate groups on regulatory issues
Liaise with external regulatory authorities as required
Draft of packaging texts, SmPCs, PILs and Prescribing Information
Review of material in accordance with The Prescription Medicines Code of Practice Authority (PMCPA)/ABPI Code
Liaise and attend meetings with other company functions to provide regulatory advice for new/existing products
Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with the statutory requirements
Lead/manage regulatory or affiliate projects and interact with other departments as necessary
Mentor regulatory staff as required
Act as deputy to the Regulatory Affairs Manager and indirectly to Director, Regulatory Affairs & QA as required
Life Sciences Degree or equivalent experience
Varied regulatory experience including clinical trials and promotional material review
The ability to thrive in a changing environment and to re-prioritise workload to meet business needs
Effective project management experience
Experience in people management would be desirable

Regulatory Affairs Project Manager Resume Examples & Samples

Project manager for regulatory projects of various sizes
Identifies, evaluates, plans, performs and implements process improvement initiatives focused on existing regulatory processes
May deliver presentations including measurement, analysis, improvement and control
Surveys and analyzes best practices for regulatory techniques and processes
Communicates team progress and performs benefit analyses
2+ years working in a regulatory environment in healthcare, pharmaceutical, Medicare or related field with Federal and/or State regulatory requirements
2+ years managing projects of various sizes
Advanced knowledge of MS Office products (Word, PowerPoint and Excel- formulas, pivots, etc.)
Proven ability to multi-task and prioritize work
Ability to research and interpret federal, state and local regulatory regulations
Ability to work with cross functional teams to ensure regulatory requirements are incorporated into the development process
Experience providing presentations to various sized groups

Regulatory Affairs Project Manager Resume Examples & Samples

A Bachelor’s degree (BS or BA) in an applicable scientific or health science field such as biochemistry, chemistry, pharmacy or pharmacology is required
At least four (4) years or more of experience with Perrigo or another company in the Pharmaceutical, medical device or other medical products/health care industry with progressive experience managing projects of complexity, is required
Hands on experience in Regulatory Affairs, or a combination of an advanced degree in Regulatory Affairs or closely allied field and relevant practical training in the field, is also required
Strong financial acumen, including capabilities in project governance and risk assessment, budget management, and the ability to organize and balance resources across project goals
Must possess excellent analytical skills and the ability to apply policies and general regulations to specific products or projects with minimal direction
Well-developed communication skills are essential, including excellent written, verbal, and interpersonal skills
Excellent documentation skills and the ability to coordinate multiple projects and priorities in order to meet required due dates is required
Travel of approximately 10% (primarily to the Perrigo Minnesota site) may be required

Regulatory Affairs Project Manager Resume Examples & Samples

Implement regulatory strategies & deliverables typically for late development and marketed products in the assigned Therapeutic Area for the WE Area (including Israel, Turkey and Switzerland). In alignment with the overarching global regulatory strategy and region specific requirements
May receive delegation to represent the Area/Affiliate regulatory requirements and interests (RA affiliates and commercial) on the Global Regulatory Product Team (GRPT) to ensure those are met. Duly reports on activities in these teams and alerts his/her management when necessary
Propose a Local Regulatory Strategic Tactical Plan (L-RSTP) in collaboration with the RA personnel in the affiliates. (Area Regulatory Product Team ARPT)
Primary RA interface with Commercial. Represent RA on the Brand Teams (provide strategic input for registration, ensure the business needs are met by anticipating and mitigating regulatory risks while ensuring compliance with regulations, assess probability of success for submission, approval and launch by country and product)
Primary interface to and from the RA personnel in the affiliates
Primary interface with local health authorities (via RA personnel in the affiliates
Receives delegation for direct liaison with EMA for products within the Therapeutic area
Provide leadership and support to RA personnel in the affiliates (through ongoing communication. Assess scientific data provided by specialist units for registration (and re-r) purposes against WE regulatory requirements, identifying gaps and developing mitigation strategies. Ensure effective presentation of data, complete and timely responses (including CTAs)
Maintain an active awareness of EU legislation and assess its impact on AbbVie business and R&D programmes jointly with RI. Develop and execute strategies to respond to those. Propose revisions. Ensure application of policies once established
Implements the EU processes to achieve local HA input into R&D Programmes and regulatory approval
Provide Area input on local implications through participation in Teams as needed (e.g., submission teams, labelling working group: development of labelling negotiations)
Ensure regulatory compliance within WE for the assigned compounds/products. Implement remediation plan to address identified gaps, if any
A Degree in pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required

Regulatory Affairs Project Manager Resume Examples & Samples

Restricted substances (e.g. REACH)
International Experience
Regulatory Operations
Submission/registration types and requirements
GxPs (GCPs, GLPs, GMPs)
International treaties and regional, national, local and territorial trade requirements, agreements and considerations
Communicate with diverse audiences and personnel
Write and edit technical documents
Work with cross-functional teams
Work with people from various disciplines and cultures
Negotiate internally and externally with regulatory agencies
Pay strong attention to detail
Juggle multiple and competing priorities
Think analytically with good problem solving skills
Define regulatory strategy
Perform risk assessment or analysis
Lead functional groups in the development of relevant data to complete a regulatory submission

Regulatory Affairs Project Manager Resume Examples & Samples

Develop new regulatory policies; processes and SOPs and train key personnel on them
Evaluate regulatory risks of division policies; processes; procedures
Provide regulatory input to product lifecycle planning
Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
Assist in the development of multi country regulatory strategy and update strategy based upon regulatory changes
Assist in regulatory due diligence for potential and new acquisitions
Utilize technical regulatory skills to propose strategies on complex issues
Determine submission and approval requirements
Identify emerging issues
Monitor trade association positions for impact on company products
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
Recruit; develop and mentor regulatory professionals
Assess the acceptability of quality; preclinical and clinical documentation for submission filing
Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions
Compile; prepare; review and submit regulatory submission to authorities
Monitor impact of changing regulations on submission strategies and update internal stakeholders
Monitor applications under regulatory review
Communicate application progress to internal stakeholders
Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
Evaluate proposed preclinical; clinical and manufacturing changes for regulatory filing strategies
Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
Provide strategic input and technical guidance on regulatory requirements to development teams
Manage and execute preapproval compliance activities
Oversee processes involved with maintaining annual licenses; registrations; listings and patent information
Ensure compliance with product post marketing approval requirements
Review and approve advertising and promotional items to ensure regulatory compliance
Ensure external communications meet regulations
Develop; implement and manage appropriate SOPs and systems to track and manage product-associated events
Actively contribute to the development and functioning of the crisis/issue management program
Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies
Report adverse events to regulatory agencies and internal stakeholders
Provide regulatory input for product recalls and recall communications
2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 4-5 years experience in a regulated industry (e.g., medical products, nutritionals)
M.S. in Regulatory Affairs/Regulatory Science is preferred
5+ years of experience in IVD assay development and/or regulatory
2-5 years of experience with IVD submissions/registrations (US and/or International)

Regulatory Affairs Project Manager Resume Examples & Samples

Coordinate and track all regulatory projects
Acts as a liaison with department and outside department personnel to fulfill project/departmental goals
Reviews deliverables prepared by team before passing to other cross-functional teams
Conduct regular status meetings with all cross-functional teams and foreign subsidiary offices to ensure projects are being completed in a timely manner
Requests, compiles, and files appropriate regulatory documentation for Product Information Files
Acts as liaison between consultants and the regulatory team to ensure all invoices are paid in a timely manner
Minimizes our exposure and risk on regulatory projects
3-5 years of Project Management or related experience
In-depth knowledge of and prior experience using MS Project or other project management software
In-depth knowledge of and prior experience using Excel
Experience coordinating and facilitating meetings
Experience working in a shared services or cross-functional model
Must be able to function under pressure in fast paced corporate environment, highly organized, meet demanding deadlines, think creatively, ability to negotiate, resolve timeline failure issues and mitigate consequences, and lead teams effectively
Ability to work across teams, groups and functions and to build strong relationships
Employee is frequently required to sit for extended periods of time and may be required to talk and listen to employees and/customers
Employee is occasionally required to stand for long periods of time; walk; use hands to finger, handle, or feel; and reach with hands and arms
Employee must regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds

Regulatory Affairs Project Manager Resume Examples & Samples

Bachelor’s Degree in any field
Must have Clinical Research Certification (CCRC, CCRA, RAC, etc.) or have adequate experience to obtain certification within 1 year of start date
The position requires extensive, diverse and progressively responsible experience at the management level, including direct responsibility for clinical research, regulatory affairs, and personnel management
Substitution: Clinical research regulatory experience may substitute for the degree only on a year for year basis. For example, 4 years of clinical research regulatory experience may substitute for the bachelor's degree, but NOT for the Clinical Research Certification
3 years of clinical research regulatory experience
Experience with/understanding of contract language
Experience with regulatory submissions to federal agencies (e.g., FDA)
Experience with University of Colorado Denver regulatory policies and procedures
Experience with filing Investigational New Drug Applications (INDs) and requesting IND exemption determinations
Ability to quickly learn, interpret and master complex protocol information
Possesses advanced knowledge of Good Clinical Practices, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials
Demonstrated commitment and leadership ability to advance diversity and inclusion
Knowledge of medical terminology and computers

Regulatory Affairs Project Manager Resume Examples & Samples

Manages FDA regulatory submission process; oversees the authorship and publication of electronic submissions
Manages the development of dossiers for registration of products in countries outside the U.S
Lead project teams while providing regulatory direction to development project teams; develops and communicates regulatory strategy for new products
Manages the development and review processes for proposed labeling for compliance with applicable U.S. and international regulations
Supervises the development of package inserts, evaluation of promotion and advertising material for compliance with applicable regulations, and reviews of proposed product changes for impact on regulatory status of the product
Interprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization
Keeps all areas of Zimmer Biomet informed of regulatory requirements and emerging issues which may affect the registration approval of products
Responsibility for oversight and prioritization of departmental tasks and projects
Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including with Regulatory agencies, superiors, peers, and direct reports
Ability to lead a team, influence others and. Strong organizational skills and development project experience qualify the occupant to lead teams and handle increasing levels of responsibilities
6-8 years of experience in Regulatory Affairs
Experience in orthopaedic or medical device strongly preferred
Regulatory Affairs Certification (US or EU) preferred
Combination of education and experience may be considered

Regulatory Affairs Project Manager Resume Examples & Samples

5 years or more project management experience required
Medical device industry experience required
Quality or regulatory experience preferred

Regulatory Affairs Project Manager Resume Examples & Samples

Minimum 5 years of Regulatory Affairs &Operations and best practices experience in several regulatory areas (including dossier preparations and submissions, variation management (including EU procedures), CMC)
IDMP knowledge
RIMS Experience (Research Information Management Systems)
Experience in working within the pharmaceutical and/or software industry
Change Management Controls
Regulatory Renewals

Regulatory Affairs Project Manager Resume Examples & Samples

Medical Master Degree or above, preferable in Endocrinology
Min 3+ years experience in RA area in pharmaceutical industry or related industry like medical devices or healthcare industry
Experience in pharmaceutical marketing, R&D or medical affairs functions is preferred

Regulatory Affairs Project Manager Resume Examples & Samples

Develops sound global regulatory strategies for new and modified medical devices
Prepares robust regulatory applications to achieve departmental and organizational objectives
Creates, reviews and approves engineering changes
Provides leadership and guidance (including training) to other members of the RA staff
Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations
Provides Regulatory leadership to development teams
BA or BS degree (degree in a technical discipline highly preferred)
Minimum 6 years regulatory experience; 8 years preferred
Experience with 510(k) applications, IDEs, PMA or PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions
Ability to work in a highly matrixed and geographically diverse business environment
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Multitasks, prioritizes and meets deadlines in timely manner
Strong organizational and follow-up skills, as well as attention to detail
Ability to travel approximately 5%, including internationally
Ability to maintain regular and predictable attendance
Ability to work independently with no oversight
Ability to identify and solve problems in a strategic manner
Ability to manage complex projects
Ability to be proactive and not reactive, to anticipate changing business and regulatory environments

Regulatory Affairs Project Manager Resume Examples & Samples

Develop regulatory submissions such as 510(k), PMA, IDE and Annual/Periodic Reports to US FDA, and Design Dossier, Technical Files and Notice of Change to EU notified body and other regulatory agencies
Maintain international technical files/dossiers/registrations as required
Participates in new product development teams, develops regulatory strategies, and provides regulatory support consistent with regulatory strategies
Reviews and approves document change orders and engineering documentation (EDC)
Interfaces with Regulatory Agencies as required
Prepares for facility registration, device listing, periodic reports etc. per U.S. FDA requirements and the requirements of foreign markets
Assembles Common Technical Document (CTD) and electronic filings for USFDA and other international regulatory agencies
Interprets, executes and recommends modification to internal guidelines, work instructions, and procedures related to regulatory affairs
Monitors industry and regulatory trends to develop strategies and provide appropriate guidance
Tracks the status of regulatory submissions during submission development and review/approval progress and communicates to management
Bachelor’s degree in Life Sciences or Engineering
5+ years medical device regulatory affairs experience with USFDA and international submissions
Knowledge of US and international submission requirements and US and International regulations
Demonstrated ability to work with minimal supervision on multiple concurrent tasks/activities and meet corporate strategies and goals

Regulatory Affairs Project Manager Resume Examples & Samples

1) Serve as a mentor for Regulatory Affairs Coordinators, Associates, and Assistants
2) Develop global regulatory strategies for new and modified products
3) Prepare and submit PMA, IDE, 510(k) and international product registrations and licensing applications (original submission and subsequent product enhancements.)
4) Maintains a professional demeanor and technical expertise through familiarity with the literature, attendance at professional meetings and participation in team meetings
5)Interpret new or existing regulatory requirements as they relate to AVD products and procedures

Regulatory Affairs Project Manager Resume Examples & Samples

Proactively develops action plans and implements all activities, to achieve the timely and efficient registration of high quality submissions (market authorizations, clinical trials and post-market variations) for all assigned BI products within timelines specified by Corporate Office or local Management. This includes
B.Sc. or higher degree in life sciences (e.g. pharmacology or pharmacy) with significant experience in drug regulatory affairs in a pharmaceutical industry
Thorough knowledge and understanding of federal regulations/guidelines concerning development, manufacturing and sale of pharmaceutical products
Excellent Project Management skills, i.e. superior organizational, written and oral communication skills, the ability to work independently as well as to collaborate effectively with team members locally and internationally to meet strict deadlines
Good working knowledge of business office software applications including word processing (e.g. Microsoft Word, Word Perfect), presentations (e.g. PowerPoint) and databases (e.g. Access or regulatory databases for other environments)
Candidates with less experience may be considered at the Regulatory Affairs Associate level *

Regulatory Affairs Project Manager Resume Examples & Samples

The Joseph M. Farley Nuclear Plant near Dothan, Ala
The Edwin I. Hatch Nuclear Plant near Baxley, Ga
The Alvin W. Vogtle Electric Generating Plant near Waynesboro, Ga
Performs research to develop or support formal licensing positions and strategies for potential conditions adverse to quality, issues of concern, and emerging generic issues
Counsels management and executives on regulatory planning and strategies
Advises the plant sites to address issues that have regulatory implications; performs regulatory analyses and provides insights for decision-makers
Provides expertise in plant licensing basis, as well as generic and plant-specific licensing issues
Regularly interfaces with NEI, NRC, and other utilities to develop positions and strategies for regulatory issues; being able to influence and provide industry leadership is key in this role
Is expected to serve as a mentor to other licensing engineers in the department
Availability for after-hours plant support is required
SNC emergency response organization support may be required; therefore, the selected candidate must live within one hour of the SNC Emergency Operations Facility for emergency response availability
Bachelor of Science degree in engineering from an accredited college or university is required
Ten years (10) of power plant operations or other related industrial experience is desired
Five year (5) or more years of experience in the nuclear industry is required
Previous experience managing or influencing a team of employees is highly desired
Prior NRC experience is highly desired (resident or regional inspector, NRR experience, etc.)
Working knowledge of the Reactor Oversight Process, NRC procedures, and NRC regulations
Advanced degree, professional engineering license, or other specialty certifications is a plus
Previous SRO license or certification is highly desired
Plant specific knowledge of Farley, Hatch, or Vogtle plants is desired but not required
Typically works independently to uncover and resolve complex regulatory and licensing issues
Critical decision-making ability to understand the regulatory consequences and impacts of actions
Must exhibit an exceptional degree of regulatory expertise, creativity, and resourcefulness
Working knowledge of nuclear power plant design and systems is highly desired
Working knowledge of design and licensing basis for nuclear plants is highly desired
Ability to represent SNC at NRC and industry meetings is desired
This position must possess extensive knowledge that enables them to lead and participate in professional committees
Strong technical writing skills are highly desired
Strong analytical skills are highly desired
Ability to communicate well, to make presentations to senior SNC management, and to build trusting relationships with the NRC is required

Regulatory Affairs Project Manager Resume Examples & Samples

Compile and submit drug master file for active pharmaceutical ingredients and other substances (i.e. U.S., Canada, Europe, Asia, Mexico, and South America)
Correspond with regulatory agencies and customers regarding submissions
Compile and submit responses to questions regulatory agencies have regarding submissions
Maintain schedule and complete annual reports for all regulatory submissions
Maintain records of all regulatory submissions and associated Letters of Authorization/ Letters of Access
Maintain records of all correspondence with regulatory agencies and customers
Compile and submit Site Master Files to support GMP operations
Compile technical data packages for active pharmaceutical and other substances for use by customers in the preparation of their own submissions