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Rocket Pharmaceuticals · 2 weeks ago

Senior Vice President, Regulatory Affairs

Cranbury, NJ

Full-time

Onsite

Director/Executive

$360K/yr - $400K/yr

10+ years exp

Rocket Pharmaceuticals is a fully integrated, late-stage biotechnology company focused on advancing gene therapies. They are seeking a Senior Vice President, Regulatory Affairs to develop and drive regulatory strategies for innovative gene therapy products, ensuring compliance and effective communication with regulatory authorities.

BiotechnologyGeneticsHealth CarePharmaceutical

Responsibilities

Develop and execute regulatory strategies for all clinical, non-clinical and CMC approval pathways across Rocket's pipeline, and ensure compliance with ICH guidance, FDA, EMA, and additional countries’ regulations

Leads regulatory interactions with the FDA, EMA, and other Agencies on behalf of Rocket Pharmaceuticals, while overseeing all aspects of label development and negotiation, and effectively negotiating acceptable responses to health authority inquiries

Advises leadership team and Board on regulatory strategy and execution for early and late-stage programs, CMC, nonclinical and commercial activities, as well as advice on areas of regulatory risk, and updates on new governmental/regulatory developments

Demonstrates a comprehensive understanding of current FDA and EMA gene therapy guidelines and regulations for a variety of submission documents, including INDs, BLAs, MAAs, all types of amendments, their supplements, and annual reports. This includes comprehensive familiarity with Orphan Drug (US/EU), Rare Pediatric, Regenerative Medicine Advanced Therapy (RMAT), Advanced Therapy Medicinal Product (ATMP) and PRIME designations

Ensures all outgoing FDA/EMA submissions are complete, accurate, timely and in compliance with current regulations and guidelines

Develops trust and strong relationships with Agencies based on frequent & transparent discussions

Participates in due diligence and provides regulatory advice and perspective on all potential licensing and M&A deals

Gains in-depth scientific knowledge of diseases, as well as non-clinical and clinical data supporting the development of Rocket’s pipeline programs

Demonstrates regulatory understanding of CMC gene therapy platform (LVV and AAV), Rocket’s product manufacturing process, and associated analytics knowledge

Hires, develops and manages a high-quality regulatory team

Develops and oversees regulatory operations and regulatory budget

Leads by example, an integrated leader that helps expedite program development & product approvals, while adhering to all regulatory requirements

Supporting regulatory submissions and approvals for leading programs in the US and EU

Designing and executing regulatory strategies to optimize early-stage clinical programs for multiple additional undisclosed candidates

Qualification

Regulatory Affairs LeadershipGene Therapy ExpertiseRegulatory Strategy DevelopmentBiopharmaceutical ExperienceINDBLA SubmissionsCMC KnowledgeClinical Trial RegulationsTeam ManagementCollaboration SkillsCommunication SkillsProblem Solving

Required

Advanced degree is required, such as PhD, M.D., PharmD, etc. in a relevant scientific area

10 - 15 years of biopharmaceutical leadership experience in regulatory affairs

Experience providing strategic leadership and operational excellence while managing the regulatory affairs function in a biopharmaceutical company

Experience developing broad regulatory plans for Phase 1 through Phase 4 clinical trials

Drug development and approval experience in rare disease and biologics required

Rich regulatory knowledge and experience with clinical, nonclinical, CMC and labeling aspects of global development programs

Successful regulatory submissions and achieved accelerated approvals

Experience developing and managing high-quality preparation and timely submission of regulatory documents, including INDs, CTAs, original BLAs and MAAs

Biologics and/or vaccines as well as cell and gene therapy products experience including a significant level of interaction with the relevant FDA/EMA/MHRA