Executive Director, Head of Regulatory Affairs
2 weeks ago
Job Description: Executive Director, Head of Regulatory Affairs
Reports to: Chief Development Officer
Location: Hybrid (2 days a week in Princeton, NJ office)Position OverviewThe Executive Director, Head of Regulatory Affairs position will provide regulatory expertise and leadership to ensure that the company meets its objectives. The candidate will be responsible for working with global health authorities to appropriately position PMV’s innovative products while also ensuring efficient and compliant internal regulatory operations.
This leader will be responsible for developing regulatory strategies, overseeing the filing of applications, leading and positively impacting global Health Authority interactions, and managing the team associated with these activities.
Primary Responsibilities
- Leads global strategic and operational planning, management, support and execution of regulatory activities
- Builds and manages strong relationships with cross-functional internal colleagues, as well as between the regulatory team and regulatory agencies, external CROs, regulatory consulting groups, and other third parties.
- Defines strategies for, coordinates the execution of regulatory submissions including, but not limited to: Investigational New Drug applications, New Drug Applications and equivalent international filings
- Advises project teams and collaborates cross-functionally with clinical, preclinical, pharmaceutical development, commercial and external resources on Regulatory Affairs issues to promote global acceptability of programs
- Serves as a primary liaison to US FDA, EMA, and other key market Health Authorities, driving interactions and overseeing Health Authority meeting preparation throughout the organization
- Champions new ways of meeting targets and/or goals, risk mitigation strategies, facilitates the rapid transfer of best practices and explores critical issues not explicitly addressed by others
- Develops and maintains responsive, motivated and efficient teams to ensure results orientation and continuous improvement
- Develops policies and procedures, as needed
- Manages, coaches, and mentors direct reports
- Bachelor’s degree in a scientific discipline is required, advanced degree is a plus
- Minimum of 10 years of progressively increasing experience in a pharmaceutical or biotechnology organization including significant experience in a Regulatory Affairs leadership role
- Oncology experience required
- Regulatory CMC and CDx experience is preferred
- In-depth knowledge of relevant regulatory guidelines and requirements, with a focus on the US and EU
- Proven record of success in gaining regulatory approval through relationship building with global health authorities; experience with INDs, NDAs, CTAs, and post-marketing/life cycle management (e.g. variations, renewals, labeling)
- Familiarity with Chemistry, Manufacturing, and Control (CMC), Pharmacovigilance and Quality, related aspects and their intersection with Regulatory Affairs
- Demonstrated leadership ability and experience managing, coaching and mentoring direct reports and building or growing a regulatory affairs function
- Excellent verbal and written communication skills
- Successful management of projects to completion meeting budgets and timelines
- PMV provides a competitive medical benefits package, a generous PTO policy, competitive salaries, Employee Stock Purchase Plan, Employee Referral Program, and much more.
Powered by JazzHR
Yh6M91W3IT
-
Executive Director, Head of Regulatory Affairs
23 hours ago
Princeton, United States pmvpharma Full timeJob DescriptionJob DescriptionPMV Pharmaceuticals Inc.Job Description: Executive Director, Head of Regulatory AffairsReports to: Chief Development OfficerLocation: Hybrid (2 days a week in Princeton, NJ office)Position OverviewThe Executive Director, Head of Regulatory Affairs position will provide regulatory expertise and leadership to ensure that the...
-
Princeton, United States pmvpharma Full timePMV Pharmaceuticals Inc. Job Description: Executive Director, Head of Regulatory Affairs Reports to: Chief Development Officer Location: Hybrid (2 days a week in Princeton, NJ office)Position Overview The Executive Director, Head of Regulatory Affairs position will provide regulatory expertise and leadership to ensure that the company meets its objectives....
-
Senior Director Regulatory Affairs
Found in: Appcast US C2 - 2 weeks ago
Princeton, United States SUN PHARMA Full timeThe Brands and Innovative Medicines Global Regulatory Affairs organization is seeking a Senior Director, Global Regulatory Portfolio Leader. Working with leaders across the organization, this individual will provide leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas and develop a team of US...
-
Senior Director Regulatory Affairs
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
Princeton, United States SUN PHARMA Full timeThe Brands and Innovative Medicines Global Regulatory Affairs organization is seeking a Senior Director, Global Regulatory Portfolio Leader. Working with leaders across the organization, this individual will provide leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas and develop a team of US...
-
Director Regulatory Affairs
1 week ago
Princeton, United States TK-CHAIN LLC Full timeSUMMARY OF POSITION ORGANIZATION STRUCTURE The Director, Regulatory Affairs reports into the VP, Regulatory Affairs and is based in Pine Brook, New Jersey. Manages team of 2-5 direct and indirect reports. RESPONSIBILITIES QUALIFICATIONS - Advanced degree in a life science.Minimum of 12 years of pharmaceutical industry experience, at least 10 of those...
-
Director Regulatory Affairs Strategy
1 week ago
Princeton, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...
-
Director Regulatory Affairs Strategy
3 weeks ago
Princeton, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...
-
Director Regulatory Affairs Strategy
23 hours ago
Princeton, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...
-
Director Regulatory Affairs Strategy
24 hours ago
Princeton, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...
-
Director of Regulatory Affairs
1 week ago
Princeton, United States BioPhase Full timeHybrid - 3 days a week in office - Princeton, NJ The Associate Director of Regulatory Affairs Labeling will assist in the development of a cross-functional labeling strategy for products worldwide, including providing expert input on labeling requirements and strategic guidance during label development, facilitating cross functional labeling discussions...
-
Director of Regulatory Affairs
4 days ago
Princeton, United States BioPhase Full timeHybrid - 3 days a week in office - Princeton, NJ The Associate Director of Regulatory Affairs Labeling will assist in the development of a cross-functional labeling strategy for products worldwide, including providing expert input on labeling requirements and strategic guidance during label development, facilitating cross functional labeling discussions...
-
Director of Regulatory Affairs
Found in: Appcast US C2 - 2 weeks ago
Princeton, United States BioPhase Full timeHybrid - 3 days a week in office - Princeton, NJ The Associate Director of Regulatory Affairs Labeling will assist in the development of a cross-functional labeling strategy for products worldwide, including providing expert input on labeling requirements and strategic guidance during label development, facilitating cross functional labeling discussions with...
-
Manager Regulatory Affairs
1 week ago
Princeton, United States TK-CHAIN LLC Full time**SUMMARY OF POSITION** Manages team and leads Regulatory Associates and/or Senior Regulatory Associates in regulatory activities associated with planning, authoring, compiling and submitting highest-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Plans, coordinates,...
-
Associate Director of Regulatory Affairs
Found in: Appcast Linkedin GBL C2 - 3 weeks ago
Princeton, United States BioPhase Full timeHybrid - 3 days a week in office - Princeton, NJ The Associate Director of Regulatory Affairs Labeling will assist in the development of a cross-functional labeling strategy for products worldwide, including providing expert input on labeling requirements and strategic guidance during label development, facilitating cross functional labeling discussions with...
-
Vice President Regulatory Affairs Quality Assurance
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
Princeton, United States Afton Consulting Group Full timeVice President of Regulatory Affairs & Quality AssuranceAre you a seasoned expert in pharmaceutical regulatory affairs and quality assurance? Do you crave the challenge of leading these critical functions within a dynamic, innovative organization? If so, this opportunity could be a pivotal career move.The Role:The Vice President of Regulatory Affairs &...
-
Vice President Regulatory Affairs Quality Assurance
Found in: Appcast US C2 - 2 weeks ago
Princeton, United States Afton Consulting Group Full timeVice President of Regulatory Affairs & Quality AssuranceAre you a seasoned expert in pharmaceutical regulatory affairs and quality assurance? Do you crave the challenge of leading these critical functions within a dynamic, innovative organization? If so, this opportunity could be a pivotal career move.The Role:The Vice President of Regulatory Affairs &...
-
Princeton, United States Afton Consulting Group Full timeVice President of Regulatory Affairs & Quality AssuranceAre you a seasoned expert in pharmaceutical regulatory affairs and quality assurance? Do you crave the challenge of leading these critical functions within a dynamic, innovative organization? If so, this opportunity could be a pivotal career move.The Role:The Vice President of Regulatory Affairs &...
-
Vice President Regulatory Affairs Quality Assurance
Found in: Jooble US O C2 - 1 week ago
Princeton, NJ, United States Afton Consulting Group Full timeVice President of Regulatory Affairs & Quality Assurance Are you a seasoned expert in pharmaceutical regulatory affairs and quality assurance? Do you crave the challenge of leading these critical functions within a dynamic, innovative organization? If so, this opportunity could be a pivotal career move. The Role: The Vice President of Regulatory Affairs...
-
Princeton, United States Kyowa Hakko Kirin Full timeThe Project Manager, Global Regulatory Affairs Compliance and Planning will lead or support regional and global projects by effectively delivering assigned projects within GRA on time and within budget. This individual will support the develop of per Project Manager, Regulatory Affairs, Compliance, Planning, Manager, Regulatory, Business Services
-
Regulatory Business Analyst
Found in: beBee S US - 2 weeks ago
Princeton, United States QData Full time10+ Years of experience is mandatory. The Business Analyst will engage and partner with cross-functional business teams to gather business requirements perform gap analysis develop functional requirements define solution recommendations draft business cases perform vendor research partner with internal and external development and testing teams to...
