Senior Vice President, Regulatory Affairs

Rocket Pharmaceuticals • Cranbury, NJ

87d • $360,000 - $400,000

About The Position

Work at ROCKET PHARMA and help cure rare diseases! Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.

Requirements

• 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.
• Experience with pivotal trials, product registration and BLA/MAA regulatory approval strongly preferred.
• 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.
• First-hand experience with gene therapy products and vaccines is preferred.
• 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.
• A track record leveraging Priority Review, Orphan Products, Breakthrough/RMAT, PRIME, Fast Track and/or Accelerated Approval designations.
• CDER/CBER and EMA experience.
• 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.

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.
• 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.

Benefits

• Competitive total rewards package including bonuses (short-term incentives).
• Medical, dental, and vision insurance.
• Life insurance.
• 401(k) with company match and generous vesting.
• Paid vacation and holidays.
• Global shutdown days between Christmas and New Year’s.
• Variety of wellness resources and employee support programs.
• Equity awards (long-term incentives) for certain positions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 251-500 employees