Director, Regulatory Affairs Resume Samples

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V Murphy

Verner

Murphy

4131 Travon Lodge

Dallas

+1 (555) 799 7226

4131 Travon Lodge

Dallas

Phone

p +1 (555) 799 7226

Experience Experience

San Francisco, CA

Director, Regulatory Affairs

San Francisco, CA

Rogahn-Denesik

San Francisco, CA

Director, Regulatory Affairs

Provide input to regulatory CMC strategies for Network changes, based upon limited information to support Network strategy and planning
Cultivate and foster collaborative relationships with internal and external partners to drive on-time, high quality delivery of business commitments
Manage the CMC books of business and schedules of Network CMC activities to support efficient, on-time execution of high-quality CMC submissions. Negotiate and communicate priorities to ensure delivery of the right work at the right time
Escalate potential delays or performance issues in a timely manner to impacted, cross-functional stakeholders and lead resolution
Provide regular feedback to vendor management and internal teams to manage and rectify performance issues
Manage communication and change management within the internal organization
Support of annual business planning and the analysis of the annual financial plan related to external partner expenditures

Houston, TX

Director Regulatory Affairs Strategy

Houston, TX

Kertzmann, Swift and Spencer

Houston, TX

Director Regulatory Affairs Strategy

Conduct regulatory due diligence on potential in-licensing opportunities
Train the GRS and the oversight and review of submissions
Develop the local and global regulatory project goals from development through life cycle
Supervise the development of multiple project goals on a local and global level
Supervise regulatory members of the global project team
Represent Global Regulatory Affairs on directly assigned global Project Teams
Develop Regulatory Strategy for directly assigned projects by designing and assessing regulatory strategy options on a regional and global basis (as outlined in the Global Regulatory Plan)

present

San Francisco, CA

Director Regulatory Affairs Oncology Precision Medicine

San Francisco, CA

VonRueden, Kreiger and Ondricka

present

San Francisco, CA

Director Regulatory Affairs Oncology Precision Medicine

present

Provide CDX regulatory leadership to assigned projects
Responsible for development of global dossier summary documents for CDx
Applies the least burdensome approach to preparation and submission of CDx regulatory dossiers
Responsible for the Dx regulatory strategy that is aligned with the Drug/Diagnostic Co-development including partnering with DRA and the regions to fulfill the business objec-tives for CDx test(s)
Responsible for leading the coordination and implementation of regulatory readiness with other line function within OPM and DRA. This is includes Diagnostics Development, Di-agnostic Program Directors, Biostatistics, Clinical Affairs, Quality Assurance and external diagnostic partners
Develop and ensure diagnostic regulatory input around PoC and during clinical develop-ment to Technical and Clinical Development teams for companion diagnostic tests
Lead the development of training for key stakeholders internal and external of the OPM unit (DRA, GPT, OPM Subteams)

Education Education

Bachelor’s Degree in Chemistry

Northwestern University

Bachelor’s Degree in Chemistry

Skills Skills

Acknowledged track record and expertise in this specialist field
Ability and willingness to travel internationally
Exceptional ability to conceptualize, develop and manage timelines
Excellent negotiation skills
Good understanding of the drug/biologics development process
Excellent written and verbal communication skills
Excellent communication (oral, written) and presentation skills necessary for interaction health authorities (FDA), senior leaders across Celgene, and cross-functional teams
Demonstrated ability to form strong working relationships across functional boundaries
Excellent planning and organizational skills
Strong interpersonal skills

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Director Regulatory Affairs Oncology Precision Medicine Resume Examples & Samples

Provide CDX regulatory leadership to assigned projects
Develop high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans
Lead program efforts relative to premarket submission, diagnostic partnering, FDA inter-face, regulatory policy and practice
Responsible for the Dx regulatory strategy that is aligned with the Drug/Diagnostic Co-development including partnering with DRA and the regions to fulfill the business objec-tives for CDx test(s)
Responsible for leading the coordination and implementation of regulatory readiness with other line function within OPM and DRA. This is includes Diagnostics Development, Di-agnostic Program Directors, Biostatistics, Clinical Affairs, Quality Assurance and external diagnostic partners
Develop and ensure diagnostic regulatory input around PoC and during clinical develop-ment to Technical and Clinical Development teams for companion diagnostic tests
OPM DRA lead on the OPM Subteams
Support the vision for regulatory affairs for molecular diagnostics and the action roadmap for activities with the regulatory bodies to ensure Novartis’ interests are reflected
Key lead to providing regulatory input for BD&L and M&A activities with respect to the regulatory risks and benefits of potential deals
Lead the development of training for key stakeholders internal and external of the OPM unit (DRA, GPT, OPM Subteams)
Determines and develops the global regulatory strategy and objectives for interactions with FDA/CDRH and other HA for CDx devices
Accountable for preparation and filing of HA briefing books, including coordination and planning for pre-Submission meetings with FDA
Develops and implements required plans for response to HA requests and coordination of any applicable follow-on activity
Serve as the key OPM program specific liaison with FDA and lead interactions with HAs
Works directly with the ROW OPM regulatory leads to support their OPM program interactions with the local ROW HA
Responsible for leading and implementing an integrated global strategy into regional submissions worldwide for companion diagnostics
Responsible for submission of required IDEs for therapeutic trials
Applies the least burdensome approach to preparation and submission of CDx regulatory dossiers
Responsible for development of global dossier summary documents for CDx
Responsible for facilitating timely submission and approval of PMAs
Strong knowledge and experience in leading regulatory submission and approval in the U.S. and other major regions
10 years’ work related professional experience in in vitro diagnostic, medical devices and life sciences
6-8 years’ experience in diagnostic regulatory affairs
Experience in molecular diagnostics and diagnostic development considered a plus. Knowledge of drug development and regulatory affairs requirements is an asset
Familiar with regulatory issues and challenges associated with Drug/Diagnostic co-development and companion diagnostics
Developed understanding of molecular technologies and the impact on outcomes and diagnostic results
Strong leadership capabilities working across cultures, expertise and backgrounds
Excellent negotiation skills with regulatory staff on various levels of hierarchy
Strong interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective collaboration with HA
Ability to influence cross-functional team members

Director Regulatory Affairs Development Resume Examples & Samples

Bachelor of Science degree; advanced scientific-related degree strongly preferred
10+ years pharmaceutical drug development (pharmaceutical industry or institutions) with minimum of 5 years in regulatory affairs
Strong scientific knowledge and regulatory experience applicable to the role. Solid basis in scientific approach, an ability to deal with in-depth technical information from a variety of disciplines and a proven, successful track record of establishing and maintaining a high degree of scientific credibility with regulatory authorities
In depth technical and regulatory knowledge of the requirements for compliance with GMPs, GLPs, GCPs and an in depth knowledge of regulatory requirements including ICH guidance
Demonstrated successful experience in applying current and evolving regulatory requirements to projects/programs
Ability to navigate a globalization organization and to act globally and regionally as appropriate
A proven track record in leading submissions, interactions with regulatory authorities, approvals and complex programs applicable to the responsibility of the specific role
Excellent interpersonal, verbal and written communication skills with a demonstrated ability to resolve conflict situations and influence regulatory authorities, as well as internal and external stakeholders
Roles within a GRA TAH require a proven track record in global development including alignment and success in association with global regulatory strategies and a demonstrated ability to effectively lead a matrixed team
Proven leadership and negotiation skills

Senior Director Regulatory Affairs Resume Examples & Samples

Conduct proactive surveillance on primary and secondary sources of regulatory intelligence information, e.g. agency websites, databases, competitor websites, journals
Analyze information and potential impact on Mallinckrodt products and processes for relevant therapeutic areas and regulatory topics
Engage closely with the Sr. Director of Public Policy and the Sr. Policy Counsel to ensure that all policy risks and opportunities facing the company are monitored and analyzed
Provide regular updates to Science and Technology leadership, Investor Relations, Government Affairs, and other applicable departments regarding Agency action or guidance applicable to the company
Assist with the facilitation of company responses to regulatory authority invitations for public/industry comment on regulatory guidances and rules, in coordination with the Sr. Director of Public Policy and Sr. Policy Counsel, as appropriate
Maintain awareness of evolving indications of interest and regulatory hot topics and reprioritize as dictated by business requirements
Maintain knowledge of regulatory requirements and guidelines and competitor products
Provide responses to information requests and other regulatory enquiries from stakeholders
Initiate process improvements and contribute to global process improvements for the functional area
Develop a process for gap/feedback analysis, set performance objectives and develop associated metrics to drive continuous improvement
Attend seminars and other industry leading forums for self-development, network expansion and information sharing across the stakeholder continuum
Work with other regulatory team members and the Government Affairs organization to provide input into improvement of systems and/or processes
Provide insight into current directions in the regulatory environment, such as updates on warning letters, FDA meetings, etc
Facilitate access to high-value, frequently referenced Regulatory Intelligence tools
Review current policies and practices issued by Federal regulatory agencies and update management as appropriate
Review regulatory guidelines and publications to keep apprised of new regulatory developments
Receive project assignments from supervisor while maintaining management of timelines for projects with minimal supervision
Minimum of ten (10) years of relevant experience in Regulatory Affairs or related field
Experience working in FDA or related agencies helpful
Experience in a Regulatory Intelligence role is desirable
Active membership in pharmaceutical organizations groups is an asset
Regulatory Affairs Certification (RAC) is desirable
Must be articulate in both written and oral communications. Must be able to review, interpret, and discuss governing regulations, precedent interpretations and applicability
Must be adept at independent decision-making and be proficient at leading discussions of complex topics
Must have excellent organization skills, ability to work on a number of projects with tight timelines, attention to detail, excellent verbal and written communication skills and interpersonal skills
Must have demonstrated effectiveness in collaboration and teamwork with judgment/problem solving and analytical skills, ability to proactively seek and find information using electronic resources, and must be knowledgeable of the regulatory environment in North America
Must have a working knowledge of Microsoft Office suite (Outlook, Excel, PowerPoint, Word)
Work is performed under limited direction of a senior Regulatory Affairs professional

Assoc Director, Regulatory Affairs Resume Examples & Samples

Charter and manage deal-specific GRACS integration team(s) comprised of representatives from the impacted functions/ processes; responsibility will include (a) driving development of GRACS-wide Day 1, 30/60/90 and End-State Integration Plans; (b) identifying & ensuring alignment of interdependent activities across the impacted business areas; and (c) driving execution of the integration plans through to project close-out
Contribute to standard integration processes & tools and actively contribute to continuous improvement of our integration capability
Collaborate effectively with external vendors/contractor staff brought in to augment existing support for deal specific execution
Work alongside Merck Integration Management Office (IMO) as primary point of contact from GRACS for deal execution. Ensure alignment with the functions represented at the IMO. Proactively raise concerns that the IMO or a subteam should address. Work with ex-GRACS functions outside of the IMO meetings as necessary to resolve issues and keep the GRACS integration on track
Assess the regulatory impact of any proposed legal entity restructuring/integration (LEI). Provide input back to the IMO, followed by a detailed regulatory implementation plan to execute the LEI with no disruption to the business. Monitor the implementation plan to completion
Ensure that best practices from each integration are captured via the GRACS M&A Playbook or other mechanism. Collaborate as necessary with ex-GRACS functions to refine the collective integration experience within Merck and find ways of working more effectively together in the future
Minimum of 7 years’ experience in the pharmaceutical industry in a regulatory, R&D, or manufacturing capacity
Knowledgeable of regulatory, CMC, and global safety processes for pharmaceutical products, vaccines and/or biologic products
Working knowledge of product-based pipeline teams at Merck through direct or support roles
Demonstrated project management experience
Demonstrated experience in leading cross-functional teams

Director, Regulatory Affairs Resume Examples & Samples

Provide input to regulatory CMC strategies for Network changes, based upon limited information to support Network strategy and planning
Cultivate and foster collaborative relationships with internal and external partners to drive on-time, high quality delivery of business commitments
Build Network CMC resource requirements and manage processes to support one or more vendor partner team(s) to enable execution on project deliverables
Manage the CMC books of business and schedules of Network CMC activities to support efficient, on-time execution of high-quality CMC submissions. Negotiate and communicate priorities to ensure delivery of the right work at the right time
Actively monitor, facilitate, report and communicate progress against agreed timelines and proactively resolve issues to enable delivery of high-quality, on-time submission information
Escalate potential delays or performance issues in a timely manner to impacted, cross-functional stakeholders and lead resolution
Collaborate with internal teams and external parties to ensure best possible delivery of Network deliverables through clearly defined objectives and actively managing and tracking overall performance (via metrics) for internal teams and assigned vendor(s)
Monitor quality of CMC deliverables and provide regular reports to management on the performance of vendors, ensuring quality, regulatory conformance and timing deliverables are met
Provide regular feedback to vendor management and internal teams to manage and rectify performance issues
Lead the development of business requirements (i.e. resource estimates, processes, SOPS, etc.) with the cross-functional teams and external business partners in support of the RPI and RFP processes
Manage communication and change management within the internal organization
Support of annual business planning and the analysis of the annual financial plan related to external partner expenditures
Develop creative and imaginative approaches to challenges and flexibly respond to changing priorities or unexpected events
At least 15 years or more of experience in pharmaceutical industry (10 years with an advanced degree) with proficiency in CMC for pharmaceutical products, vaccines and/or biologic products that includes working with external partners
Minimum 5 years working in Regulatory CMC
Strong experience with leading successful delivery of projects (pipeline, business improvement, and/or change management projects)
Strong negotiation, interpersonal, written/oral communication, leadership skills and fluent in English language
Ability to lead by influence and work effectively in matrix organizational structures
Expert at motivating individuals and teams
Project Management experience

Assoc Director, Regulatory Affairs Resume Examples & Samples

Collaborate closely with key business leaders and SMEs to understand and proactively plan for new regulations and business needs impacting the systems supporting Global Safety
Accountable for review and approval of business related System Development Life Cycle (SDLC) documentation and activities for the systems supporting Global Safety
Partner with MRL IT to enable new system development, enhancements and change requests for applications supporting Global Safety including any integration with other systems
Collaborate with the Process and Sub Process owners to ensure systems meet business process requirements and that business process or system changes and releases are in alignment
Accountable and responsible for coordinating internal change requests from the business including recommending changes/innovative enhancements
Accountable and responsible for coordinating with the business the release planning and assessment for internal and vendor change management processes including assessing the impact to any related or downstream systems
Provide strategic direction to Safety Management Business System Owners to ensure system updates have appropriate change management, communication management and business realization monitoring commensurate with changes being implemented
Accountable and responsible for directing and overseeing user acceptance testing (UAT) strategy and execution for system changes impacting Global Safety
Responsible for ensuring appropriate training materials and supporting documentation are created or updated to support the use of the systems supporting Global Safety
Responsible for ensuring system compliance with Company, local laws and agency regulations and guidance documents
Candidate is required to have at least 8 years of Clinical Safety and Pharmacovigilance experience or related areas such as Clinical or Regulatory
Strong working knowledge of PV regulations and safety systems for collection, reporting and analysis of adverse event information
In-depth understanding of business processes and objectives of customers
Function at a high level of autonomy
Excellent written and verbal communication skills including presentations to senior management

Director Regulatory Affairs, Development Resume Examples & Samples

Ph.D., or Pharm.D degree preferred
Pharmaceutical / biotechnology industry experience, which shall include 8 years’ experience in Regulatory Development (US or globally) with experience in US regulatory submissions and approvals
Post approval experience
Experience in other relevant functions will be considered. #LI-SA

Executive Director, Regulatory Affairs Resume Examples & Samples

Generally requires at least 15 years' experience with demonstrated knowledge and understanding of the communications industry and related federal and state laws and regulations
Strong negotiating and writing skills required
Ability to work in a fast-paced, ever-changing environment
Demonstrated project management and organizational skills, including the ability to work independently on multiple projects of high complexity with minimal supervision
Consistent exercise of sound, independent judgment and discretion in all matters of significance
Strong computer skills and proficiency with Microsoft office suite of products
Bachelor's Degree or Equivalent. Relevant graduate degree a plus

Assistant Director Regulatory Affairs Medical Devices Resume Examples & Samples

Provides guidance and oversight to Project Teams involving technical regulatory matters in support of new development and maintenance work for Bayer’s pharmaceutical and medical device product portfolio. Develops the technical regulatory strategy for assigned projects by assessing relevant requirements and providing interpretation and guidance of these requirements to development teams. Coordinate/review supportive data to ensure high quality and technically correct dossiers in accord to established timelines
Interprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization on relevant technical matters
Implements local and global regulatory project goals from development through life cycle. Provides technical regulatory support for the development of multiple project goals on a local and global level
Represents Global Regulatory Affairs on global Project Teams
Ensure the accuracy, scientific consistency, and compliance to local and global HA regulations and completeness of submission data
Maintain up-to-date knowledge on international and domestic regulatory requirements and their relevance to Bayer’s product portfolio
Assist, as needed, with preparations for meetings and teleconferences with local and global HA officials
Assist, as needed, with regulatory due diligence on potential in-licensing opportunities

Director, Regulatory Affairs Resume Examples & Samples

Establish the global regulatory strategy for a variety of novel therapies directed at the challenges in structural heart disease
Partner with the R&D and Clinical Affairs departments in the development and implementation of multiple clinical and regulatory strategies to ensure pre-clinical and clinical trials meet appropriate regulatory requirements
Interact with the FDA and other approval authorities to negotiate evidence needs, and facilitate global approval of emerging technologies. Oversea communications regarding a variety of novel therapies with all regulatory agencies; represent the company to agencies and trade associations
Grow and develop the Advanced Technology Regulatory Affairs team; serve as a member of the Advanced Technology and Edwards Regulatory Affairs leadership teams
Facilitate new product development through a committed partnership with R&D, Manufacturing, Marketing and Clinical Affairs throughout all phases of the product development process
A bachelor's degree in a related science or engineering discipline required. A related advanced degree is preferred
Extensive knowledge of global regulatory for cardiovascular medical devices, including surgical and interventional devices required. Experience with heart valves, and experience with Nitinol implants, strongly preferred. Experience working in emerging therapeutic areas strongly preferred
Proven track record of managing positive interactions with the FDA and other regulatory authorities, in addition to ensuring that standards of Edwards' communication and correspondence with regulatory bodies are maintained and documented
Ability to operate effectively in a culturally diverse organizational structure, in addition to working independently with limited management oversight, is required
Experience working globally and with global teams
Possess a broad knowledge of surrounding areas including Quality, Clinical Affairs, Manufacturing and Development

Director Regulatory Affairs Resume Examples & Samples

Directs activities associated with global regulatory registration of IVD medical devices. Directs submission activities for a variety of device regulatory approvals including CE mark, US PMAs, US 510(k), post-approval reports, annual reports, export certificates, establishment registrations and device listings
Supervises maintenance of product technical files and ongoing activities related to compliance with Global Regulatory directives and regulations
Provides and coordinates provision of regulatory support to related project core teams
Provides strategic support to currently marketed products, e.g., review design and process changes, labeling, promotional material, and documentation for compliance and for changes requiring regulatory agency approval or notification, as pertains to US regulatory requirements
Reviews and approves product labeling and related customer and public communications
Ensures complete and timely submission of regulatory documents to authorities
May negotiate RTD interests with regulatory bodies as directed
May interface with program development teams in developing regulatory strategies
Educates and broadens the regulatory knowledge within the RTD Lifecycle Leadership Team and RTD Pharma partners
Monitors the development of new requirements and regulatory procedures and advises senior management of the impact on the business or development projects
Manage direct report Regulatory personnel including recruitment, training, coaching, development, assignments, coordination of workload priorities and performance management

Executive Director, Regulatory Affairs Resume Examples & Samples

Develop and execute FCC strategy with respect to priority issues for the company. Meet regularly with business representatives, Legal Regulatory and outside counsel to ensure regulatory policy alignment with short-term and long-term business initiatives. Provide strategic counsel and recommendations to business based on regulatory developments. Advise business on a regular basis of developments in relevant FCC proceedings and develop strategies, with business input, to achieve positive policy results
Use established relationships with key FCC staff and industry to monitor and influence policy decisions on matters that affect company's business and regulatory obligations. Communicate company's leadership role on issues of importance to the Commission
Manage external legal resources, in coordination with Law, for relevant issues and proceedings. Provide outside counsel insight into business priorities and develop regulatory advocacy to support them
Coordinate with other GA teams to develop and execute strategies in support of federal priority regulatory initiatives. Advise on implications of state and federal legislation and state regulatory proposals on federal regulatory proceedings and advocacy
Provide strategic counsel and recommendations to business related to company representation on FCC advisory committees. Advise business representatives on FCC committees on an ongoing basis on matters relating to interaction with FCC staff and industry representatives and strategy for advancing company's leadership role

Director Regulatory Affairs Resume Examples & Samples

Oversee the development of product regulatory strategies
Develop appropriate SOPs, processes and procedures to ensure compliance with regulations
Provides directional guidance to the business on how to prepare products for approval
Review and provide input on departmental policies and procedures
Oversee the preparation of U.S. submissions
Ability to read, analyze and interpret associated regulations
Manage assigned personnel
Other job responsibilities as needed
15+ years relevant medical device industry and regulatory experience; 10 + years in Class II and III devices
Ophthalmic device regulatory experience, a plus
Must demonstrate mastery in the following core competencies: influence key stake holders, business acumen, project management, relationship building, regulatory expertise
Bachelor’s degree in science or health related field; advanced degree a plus (PhD, MD, MS, PharmD, or equivalent)
Director level title is commensurate with previous experience and title. May also hire at the Manager or Sr. Manager level

Executive Director, Regulatory Affairs CMC Resume Examples & Samples

Define the CMC regulatory strategy supporting efficient drug development for early and late-stage products through commercialization and lifecycle management
Oversee planning, preparation, and submission of clinical trial applications and marketing applications in the US and internationally
Oversee maintenance of approved products and support global commercialization of these products
Oversee all CMC interactions with global regulatory health authorities
Manage and mentor director-level direct reports
Support executive team on due diligence, regulatory intelligence, and regulatory affairs initiatives
Serve on senior staff committee responsible for developing and implementing department policies
Minimum of 6 years of experience in managing regulatory staff
Prior experience in submitting marketing applications, obtaining approvals, and maintaining the licenses for drugs and/or biologics in the US and internationally
Skilled at gathering regulatory intelligence and developing product approval strategies
History of managing multiple director-level regulatory affairs professionals
Demonstrated leadership in defining novel approaches to product development and approval
Proven track record of successfully interacting and negotiating with global regulatory health authorities
Prior experience leading cross-functional teams in the coordination of regulatory submissions and successfully managing projects to deadlines
Thorough understanding of global regulatory environment and relevant drug development regulations and guidelines, with a CMC emphasis
Outstanding interpersonal and communication (written and verbal) skills
History of solving regulatory problems while exhibiting superior judgment and a balanced, realistic understanding of issues

Director, Regulatory Affairs Resume Examples & Samples

Provide Regulatory Leadership on the development of biomarkers, companion diagnostics and associated devices. Its purpose is to help guide early development decisions by providing cutting edge regulatory strategy, and laying out the pathway to facilitate research and development of personalized therapies
To provide expert know-how on regulatory requirements for the validation of biomarkers, development of companion diagnostics, and devices, globally, especially in the US and Europe
To partner with global regulatory project leads and senior regulatory colleagues, to provide advice and guidance on drug/biologic development programs, especially to work alongside the Regional VPs (Americas, Europe), three Global TA Heads (US)
Lead regulatory strategy for biomarker to Companion Diagnostic transition
To extend Celgene’s reach into key FDA capabilities (such as CDER, CBER and CDRH) to enable effective communications, dialogue and facilitated submissions that provide for efficient development of biomarkers, companion diagnostics and devices
To work alongside the discovery, development and Translational Medicines functions to provide seamless regulatory input that adds value to, and supports effective development decisions
To work alongside Drug Safety function to evaluate safety parameters and develop risk management & risk mitigation strategies
To work alongside the VP Regulatory Intelligence & Policy to ensure cutting edge know-how is available to Celgene and that the ability to influence events in a rapidly evolving regulatory environment, is facilitated
To ensure and assure compliance of Celgene programs with regulatory requirements for diagnostics and devices
Proven track record of development of in vitro diagnostics is a requirement

Director, Regulatory Affairs & Compliance Resume Examples & Samples

This position will have responsibility for driving and maintaining regulatory compliance across the U.S. Pharmaceutical division of McKesson as assigned. This may include, but not be limited to distribution compliance to regulations under the purview of federal agencies such as DOT, DEA, EPA, FAA, FDA, as well as state agencies. The position will also include driving and maintaining regulatory compliance under other relevant regulatory areas such as CAN-SPAM, Fraud & Abuse, HIPAA, TCPA among others
Collaboratively manage relevant risk assessments for the ongoing identification of regulatory compliance needs for business relationships with federal, state and local government entities
Collaboratively manage the implementation of policies and procedures to ensure that they are in compliance with appropriate regulations and ensure relevant reporting requirements are met
Participate or lead the resolution to compliance problems, questions, or complaints received from other units of the company, customers, regulatory agencies, etc
This position may develop and implement programs designed to increase employee awareness and knowledge of compliance programs as well as may audit and evaluate current policies, procedures and documentation related to regulatory compliance
This role may also prepare documentation and reports after interpretation of federal, state or other relevant regulations for submission to other units of the company, customers, regulatory agencies, etc
8+ years experience in compliance or similar experience
Demonstrated leadership skills by leading compliance projects and initiatives
Previous experience managing and driving execution of programs collaboratively in a highly matrixed environment
Working experience in either a healthcare, pharmacy, hospital or distribution environment
Working ability in Microsoft Office Suite
Experience working in pharmaceutical distribution, pharmacy or similar area is desirable
Ability to communicate and present clearly
Relevant Compliance Certifications or Licensure Preferable

Senior Manager / Director, Regulatory Affairs Resume Examples & Samples

Recruit, manage, develop and mentor regulatory professionals
Provide regulatory input to product lifecycle planning
Assess the acceptability of quality, preclinical and clinical documentation for submission filing
Prepare regulatory submissions
Review and approve labeling to ensure compliance with regulations and company policy
Assess external communications relative to regulations
Review and approve required reports, supplemental submissions and other post-marketing commitments to update and maintain product approvals and registrations
Provide regulatory input for and appropriate follow-up to inspections and audits
Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events
Accompany inspection team(s) as required
Function as authorized delegate for function head when required
Minimum of eight years knowledge and experience with regulatory requirements for medical devices (IDE’s, PMA’s, 510(k)’s, CE mark technical files and design dossiers) with prior experience supervising regulatory affairs professionals
Previous experience in supporting regulatory projects and R&D/Quality teams
Familiarity with drug/device combination products preferred

Director, Regulatory Affairs Resume Examples & Samples

Responsible for compliance with applicable Corporate Policies and procedures
Bachelor's degree (or equivalent); Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is beneficial. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
12-18 years experience in a regulated industry (e.g., medical devices, combination products, pharmaceuticals). 10+ years of experience in regulatory preferred and may consider quality management, or related area towards total years of experience
Regulatory history, guidelines, policies, standards, practices, requirements and precedents
Regulatory agency structure, processes and key personnel
Principles and requirements of applicable product laws
Submission/registration types and requirements
GxPs (GCPs, GLPs, GMPs)
Principles and requirements of promotion, advertising and labeling
International treaties and regional, national, local and territorial trade requirements, agreements and considerations
Domestic and international regulatory guidelines, policies and regulations
Ethical guidelines of the regulatory profession, clinical research and regulatory process
Lead functional groups in the development of relevant data to complete a regulatory submission

Director, Regulatory Affairs Resume Examples & Samples

Represent Regulatory Affairs during development projects to assure early consideration of regulatory and clinical requirements
Coordination and creation of all required submission documents to IND and CTA
Develop and implement creative regulatory strategies aimed at achieving marketing authorization and appropriate product labeling. Ensure cross functional alignment on regulatory plans and strategies
Responsible for the timely production and submission of regulatory documentation, including investigational applications (IND, CTA, etc.) in compliance with global regulatory agency requirements
Serve as primary liaison with regulatory authorities, including overseeing the writing of meeting materials, leading the preparation for meetings with regulatory agencies, and ensuring appropriate follow-up
Provide critical review of documents (SOPs, protocols, Investigator’s Brochure and reports) related to Clinical, Nonclinical or Manufacturing, as necessary
Maintain regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedent as well as knowledge of therapeutic area
Participate in the development of regulatory strategy and provide strategic input and regulatory advice to the project teams on development programs
Interface with cross-functional teams (CMC, Nonclinical, Clinical) to define contributions to submissions for regulatory submissions
Interface with global regulatory authorities, strategic partner(s), and consultants
Bachelor’s degree in a scientific discipline, Advanced degree (PhD, MS) preferred
5+ years of pharmaceutical industry experience required. At least 3 years of regulatory affairs with experience associated with global submissions
Must have comprehensive understanding of global regulatory requirements for registration, development and approval of investigational products
Excellent knowledge of global regulatory requirements and processes and filing experience (IND, CTA)
Strong interpersonal, communication, and leadership skills
Ability to review regulatory and scientific submission documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies
Demonstrated leadership and people management skills in team and departmental settings
Excellent organizational, prioritization and planning skills. Ability to work independently on projects and initiatives internally and with external vendors

Director Regulatory Affairs Resume Examples & Samples

Manages a portfolio of process improvement projects across Regulatory Affairs (RA) and related functions. Drives the process of identifying, defining, and prioritizing functional and cross-functional initiatives. Effectively manages across projects in the portfolio to ensure alignment and consistency with business strategy and to drive measurable process improvements for the organization
Identifies opportunities to improve quality, reduce cycle time, and increase operational efficiency. Leads the planning and execution of high-impact process improvement projects
Drives the Business Process Owner (BPO) effort to identify mechanisms to improve overall operational efficiency. Develops, implements, and continuously refines a framework by which these SMEs can positive contribute to process excellence across Regulatory Affairs and related functions by proactively gathering and analyzing process-related metrics
Identifies, prepares, and facilitates kaizen events and/or workshops to drive the identification and execution of process improvement initiatives. Works alongside project managers from across Regulatory Affairs to drive additional process or capital initiatives that stem from the initial process improvement workshops. Drives knowledge of process modeling and design across the organization
Develops compelling value propositions and business cases for proposed initiatives. Collaborates effectively with management, Subject Matter Experts (SMEs), Quality Systems, and peers to design cross-functional solutions
Enables global regulatory compliance by defining and executing metrics and reporting protocols to monitor RA process effectiveness and compliance across the globe; directs staff in the collection and reporting of process performance metrics for new and ongoing initiatives
Works independently in a role that demonstrates organizational influence within or across RA sub-functions and related functions. Transforms concepts into executable initiatives, and drives definition of project scope, timelines and deliverables. Seeks input from and forges agreements among sponsors regarding initiative goals and objectives
Leads project teams effectively. Escalates and drives resolution of project issues. Demonstrates effective group facilitation skills and ability to drive consensus among team members regarding process changes
May manage and/or mentor more junior team members/project managers
Bachelor’s degree in business management, information systems, engineering, math, science (e.g., biology, chemistry, pharmacy, medical), or related field
10 years’ related experience
Proven 5 years in a leadership role with strong management skills
Strong verbal and written communication skills
Ability to work effectively with diverse and global audiences and personnel
Ability to interact with senior management executives
Ability to work with cross-functional teams
Strong attention to detail and problem solving skills
Effective use of negotiation skills to resolve issues in cross-functional teams to ensure completion of assigned tasks
Ability to plan, coordinate and manage meetings involving pharmaceutical regulatory subject matter experts
10+ years project planning and management including successful implementation of highly complex business and technology initiatives
4+ years managing people
Experience serving as a business management consultant
Experience developing sub-function level business strategies

Assoc Director, Regulatory Affairs Resume Examples & Samples

Serve as a Medical Device and Combination Product CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones through product development including assessment of the probability of regulatory success together with risk mitigation measures
Lead development and execution of global product and project regulatory strategies by ensuring robust assessment of global regulatory Medical Device and Combination Product CMC requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks
Lead the development, communication, lifecycle management and review of the Medical Device and Combination Product CMC Regulatory Strategy Document for assigned projects
Provide regulatory leadership as needed in product in-license/due diligence review and product transition to the Post-Approval Pharm CMC team
Manage execution of Medical Device and Combination Product CMC documentation including IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems
Identify, communicate and escalate potential regulatory issues to Global Regulatory and Clinical Safety CMC management, as needed
Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure the approval and launch market supply of Merck pharmaceutical products worldwide
Conduct all activities with an unwavering focus on compliance
Experience in reviewing scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data
Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills
Demonstrated understanding of related fields (e.g., manufacturing, analytical, quality assurance, medical devices)
Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders
Demonstrated flexibility in responding to changing priorities or dealing with unexpected events
Demonstrated effective leadership, communication, and interpersonal skills
At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or medical device field

Director, Regulatory Affairs Strategy Resume Examples & Samples

Regulatory Knowledge: Maintains a high level of regulatory knowledge and provides regulatory advice
Agency Interactions: Acts as single point of contact to FDA for products/projects. Liaises, negotiates and leads FDA and/or EMA interactions, including appropriate documentation of the interaction, decisions and outcomes with oversight from supervisor
Dossier Submissions: Independently leads the preparation, coordination or monitoring of regulatory submissions. Interacts across Daiichi Sankyo to obtain and/or provide information/data for regulatory submissions
Registration Strategy: Leads the formulation of registration strategies for products/projects. Ensures US and/or EU registration strategies are designed and captured in the Global Regulatory Affairs Strategy Plan and ensures implementation of the strategy. Ensures registration strategies adhere to corporate objectives
Team Interactions: Provides regulatory affairs representation on project teams; may lead regulatory sub-teams. May act as single point of RA contact on cross-functional teams; fosters a global view as a member of the development team
People Management: Mentors and provides guidance to junior RA representatives in a matrix environment
Advanced degree in a scientific discipline (e.g., Masters, Pharm.D., M.D., Ph.D.) with preference for M.D. and Ph.D. JD with appropriate regulatory experience would be considered
Experience in the pharmaceutical industry (8-10 years), including direct oncology regulatory affairs with the FDA preferred
Experience with ex-US regulatory authorities would be a plus

Director, Regulatory Affairs Resume Examples & Samples

Manage projects related to CMC submissions and deliverables or CMC programs that impact business processes, organizational operations, and/or resource management capabilities to support overall Global Regulatory Affairs CMC operations and conformance
Lead the planning and creation of a detailed project plan for highly complex projects with input from identified stakeholders
Initiate and lead discussions to facilitate the refinement of the project scope, goals, and deliverables
Manage a full scale project plan with tasks through collaboration with functional representatives in internal and cross-divisional project teams
Identify appropriate resources for each task through collaboration with functional representatives
Facilitate project discussions to ensure progress and identify appropriate team actions and risks
Ensure project tasks are completed and necessary action plans are executed on to ensure progress and manage risks
Meets project objectives through management of scheduling conflicts, resource constraints, and financial forecasting
Create and manage project artifacts during all phases of the project (e.g. charter, project plan, close out report, etc)
Proactively identify and resolve project issues through collaboration with the team and escalation to the CMC leadership team as appropriate
Track project deliverables including change controls through appropriate tools and framework; report to all project stakeholders
The candidate may be required to travel to other Merck sites on a periodic basis
Knowledge and experience in one or more project management methodologies (e.g. PMP, Sigma, or Change etc.) and experience with associated toolsets (e.g. MS Project for project planning, MS Excel for data analysis and reporting)
Exposure to regulatory affairs and/or CMC either through direct experience, or via a role in R&D or manufacturing
Ability to act independently and drive projects and other requests in a proactive, forward thinking manner
Demonstrated ability to collaborate and communicate across cultures, organizational levels and disciplines
Capability to work effectively in matrix organizational structures
Demonstrated flexibility in responding to changing priorities or dealing with unexpected events

Senior Director, Regulatory Affairs Resume Examples & Samples

Negotiate and communicate effectively, both internally and externally, with cross-functional project teams, management, regulatory agencies (i.e. FDA, TUV) and business partners to ensure objectives of programs are met on time
Ensure maintenance of compliance associated with CE mark and technical files
Organize project and departmental objectives and delegate effectively
Educate internal and external customers regarding regulatory requirements
Lead Regulatory Affairs staff and directly participate on project teams

Associate Deputy Director, Regulatory Affairs Resume Examples & Samples

Designated as MassBiologics’ authorized representative to the US FDA and international regulatory agencies as applicable
Leads negotiations as primary liaison with regulatory agencies
Responsible for establishing fiscally responsible organizational strategy to ensure regulatory compliance in all jurisdictions where MassBiologics places its products as well as strategies to support CMO client products
Ensures that all aspects of MBL-sponsored clinical trials meet regulatory requirements. Set and prioritize project timelines
Manages the coordination and preparation of document packages for all regulatory submissions, internal audits and FDA inspections. Includes, but is not limited to, Biologic License Applications and Amendments (BLAs), Establishment License Applications and Amendments (ELAs), Investigational New Drug (IND) Applications and Amendments, responses to all FDA queries and inspections, labeling Transmittals for Product Labels, Circulars and Promotional and Advertising Materials
Oversees all regulatory submissions, license applications, and renewals required by regulatory agencies. Ensures that the proper documents have been compiled and submitted
Oversees regulatory document tracking systems and initiates new and improved tracking systems to meet organization’s goals
Provides input to the MassBiologics Quality System by providing technical input to the deviation and change management processes to assure consistency with current regulatory status or to initiate an appropriate regulatory submission
Recommends changes for labeling, manufacturing, marketing and clinical protocols for regulatory compliance and ensures the changes are completed
Maintains current knowledge of all applicable regulations. Responsible for circulating information to Senior Staff. Provides expert analysis and evaluation of regulations. Evaluates risk, impact and analyzes trends of government regulatory activities
Ensures that reports of Adverse Events are documented appropriately, circulated to appropriate personnel, tracked internally and submitted to FDA as needed. Submit Periodic Adverse Event Report for all licensed products every January
Prepares and submits annual reports for active IND products and BLAs
Directs Clinical Trials Operations ensuring that clinical trials are executed in accordance with MassBiologics strategy, scientific plan and Good Clinical Practices
Performs additional job related duties as required
Requires a doctorate degree (PhD, MD) and demonstrated senior leadership experience or a Bachelor’s degree and 15 years experience including senior management experience. Prior experience as a senior leader of regulatory affairs for a Biologics Manufacturing organization is required
Demonstrated ability to effectively manage: processes, others, performance, and set and prioritize departmental goals
Excellent time management and organizational skills, demonstrated ability to manage and prioritize multiple teams, multiple projects and meet deadlines
Experience in any of the following areas preferred: IND submissions, BLA submissions and ELA applications/amendments, submissions to regulatory agencies in other countries
May require frequent travel between the Mattapan and Fall River campuses
May require national and international travel
Ability to work extended and sometimes unusual hours to meet business needs

Director Regulatory Affairs Strategy Resume Examples & Samples

Provide guidance and oversight to Global Regulatory Strategists (GRS) with regard to the development and implementation of global regulatory strategies to ensure alignment to Talent Acquisition (TA) portfolio and that key regions are captured in the global regulatory strategy
Develop Regulatory Strategy for directly assigned projects by designing and assessing regulatory strategy options on a regional and global basis (as outlined in the Global Regulatory Plan)
Actively involved in decision making on all key development questions in consideration of the therapeutic area portfolio via an assessment on the probability of regulatory success
Develop the local and global regulatory project goals from development through life cycle
Supervise the development of multiple project goals on a local and global level
Supervise regulatory members of the global project team
Represent Global Regulatory Affairs on directly assigned global Project Teams
Train the GRS and the oversight and review of submissions
Ensure submissions are consistent with the TA portfolio strategy
Develop submission materials for directly assigned projects for local and global submission, guides the review process, checks for accuracy, scientific consistency, compliance to local and global Health Authority (HA) regulations and completeness of submission
Advise GRA management and/or other functional areas of regulatory trends and their relevance to the TA portfolio
Keep abreast of changes in the global regulatory environment for the project and ensure that these are strategically translated to the TA portfolio
Supervise and drive preparations for meetings and teleconferences with local and global HA officials
Conduct regulatory due diligence on potential in-licensing opportunities
M.S. degree with ten (10) years of medical research activities of which five (5) to seven (7) years include local/global regulatory experience in related TA area or B.S. degree with twelve (12) plus years of medical research activities of which ten (10) to twelve (12) years include local/global regulatory experience in related TA area
Expert knowledge of the regional and global regulations
Demonstrated interactions with local and global health authorities
Excellent communication skills, verbal and written, and strong analytical skills
Demonstrated leadership and project management skills, including cross-functional communication, interpersonal and influence-management skills
A clear understanding of cultural and business needs in leading a diverse team
Advanced technical degree Ph.D., D.V.M. or Pharm.D. in life sciences with eight (8) years in medical research activities of which three (3) to five (5) years include local / global regulatory experience in related TA area
Oncology and/or Rare Disease experience

Director, Regulatory Affairs EU / Eemea Resume Examples & Samples

Lead team of professionals responsible for regional/local management of lifecycle submissions for EU and EEMEA markets, including: market applications, post-approval submissions/variations, renewals and annual reports, for MSD pharmaceutical small molecules, biologic, and vaccines products
In coordination with MSD CMC Product Leaders, lead development of submission strategy for lifecycle submissions for EU and EEMEA markets. Participate and influence the CMC strategy for region by engagement with industry forums and BoH to pursue high priority advocacy plans
Liaise with Regional Supply Chain management team and Affiliates DRA for strategic planning and influencing change management alignment and early visibility/communication/ planning of changes impacting markets in the region
Lead right first time assembly of lifecycle submissions for markets under responsibility and coordinate with affiliates for timely and effective submission of changes to the Health Authorities
Act as subject matter expert in regulatory requirements for post approval submissions and assure maintenance of regulatory intelligence repository for regional markets under responsibility
Ensure that the CMC change management electronic systems are timely updated and maintained in alignment with the regulatory information submitted/approved externally by a Health Authority or internally by the appropriate functional area
In coordination with Affiliates DRA, act as direct liaison with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert)
Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility
Manage work activities for team members supporting the EU/EEMEA region
The candidate may be required to travel to other MSD sites on a periodic basis
Scientific degree in a relevant subject (PhD preferred, science related BSc or MSc (or equivalent) required)
A minimum of 10 years of industrial or academic experience in regulatory affairs, operations, quality assurance, and technology or development functions as practiced in the Vaccine, Biological, Pharmaceutical Therapeutics or related field
A strong background and experience in supervising a team of Regulatory professionals
A strong knowledge of the post-approval Regulatory environment within the EU/EEMEA region
Knowledge of EU/EEMEA regulatory requirements for traditional pharma/Biologics/Vaccines products
Experience in the writing and successful submission of CMC data for lifecycle management
Extensive knowledge of pharmaceutical manufacturing and packaging processes
Member of professional regulatory organization actively involved in influencing policy within the region
Strong skills in English language (written and verbal)
Experience in establishing a team and developing them to be high performers
Ability to understand the broader pharmaceutical business and align activities of team to support and enhance business value
Strong Leadership skills with proven experience in leadership of a diverse regional organization
Ability to communicate at all levels across the organization and to build strong and effective partnerships and working relationships
Robust self-reliant manager with a proven track record in decision making

Director, Regulatory Affairs & Compliance Resume Examples & Samples

This position will have responsibility for driving and maintaining regulatory compliance across the U.S. Pharmaceutical division of McKesson as assigned. The position will include driving and maintaining regulatory compliance under other relevant regulatory areas such as TCPA, CAN-SPAM, Fraud & Abuse, HIPAA, among others. This may include, but not be limited to some distribution center compliance to regulations under the purview of federal agencies such as DOT, DEA, EPA, FDA, as well as state agencies
8+ years’ experience in compliance or similar experience
Working experience in Pharmacy or Hospital, healthcare setting
Compliance experience with relevant regulatory areas such as TCPA, CAN-SPAM, Fraud & Abuse, HIPAA, among others
May require up to 30% travel

Director, Regulatory Affairs Resume Examples & Samples

Assist Global Head, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects in Medicinal Products, Medical Devices and Diagnostics ( MDD) and EU Safety Reporting by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidance’s issued by the applicable regulatory agency(ies)
Manage/oversee assembly and submission of applications to competent authorities
Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations
Act as a senior point of contact for global Regulatory consulting opportunities including Advanced Medicinal Therapeutic Products and MDD
Acts in trans functional role as Executive Oversight for assigned projects
Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations
Ensure the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects
Keep abreast of, interpret and communicate applicable regulatory agency regulations and statutes with internal departments and ensures Novella compliance
Serve as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated Novella activities, as appropriate
Participates in business development activities to grow Novella business. Participates in new business development activities including, but not limited to, client meetings and proposal preparation/presentation
Perform other related duties as assigned
Extensive knowledge of clinical research and product development life cycles for medicinal products
Extensive working knowledge of activities related to regulatory affairs, reimbursement and quality assurance, both domestic and international
Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public
Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs
Ability to read and synthesize technical material and to prepare clear and concise written documents
Comprehensive knowledge of US Good Clinical Practice (GCP), Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP) requirements,
Demonstrated experience in client service in the clinical research business
Demonstrated high energy level
Ability to handle multiple tasks and challenges simultaneously
Demonstrated ability to form strong working relationships across functional boundaries
Excellent written and verbal communication skills
Excellent negotiation skills
Exceptional ability to conceptualize, develop and manage timelines
Ability and willingness to travel internationally
Ability to travel internationally for extended periods of time
Very limited physical effort required to perform normal job duties

Director, Regulatory Affairs Resume Examples & Samples

Oversee the process of preparing product submissions to domestic and international regulatory bodies and manage the process from inception to approval
Interact with FDA, including preparation of PMA/IDE/510K submissions
Manage relationship with international regulatory agencies
Plan, review, approve required documents from various departments for filing of required information to FDA, including, pre-IND and other consultations with FDA, new IND's, updates to IND's, and original/supplemental NDA filings
Provide regulatory review of study protocols, investigator’s brochures, labeling, and integrated summary documents
Collaborate with EU regulatory to develop global approval strategies
Provide regulatory advice and guidance to project teams to ensure submissions meet regulatory requirements; and
Maintain up-to-date knowledge of regulatory requirements
Bachelor’s Degree in a related field
A minimum of 10 years of Regulatory Affairs experience in the device industry
Experience working in a small, global company is preferred
Strong computer skills, project management skills, and a high attention to detail; and
Strong communication skills (both written and oral)
This position may require supervision of junior level staff