Senior Vice President, Regulatory Affairs

Rocket Pharmaceuticals-posted 7 days ago
$360,000 - $400,000/Yr
Full-time • Executive
Cranbury, NJ
251-500 employees
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Create a future where DNA is no longer destiny. Join Rocket Pharma. Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene therapy cures. Rocket places tremendous value on our people and fosters a collaborative environment where bold ideas thrive and every team member makes a meaningful impact. Our core values guide everything we do: we trust one another, show generosity toward patients, embrace curiosity, and strive to elevate science. Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits. Position Summary As Rocket prepares for continued growth, they are at an inflection point where a senior level regulatory affairs leader will be pivotal. The incoming Senior Vice President (SVP), Regulatory Affairs will be a key member of the senior leadership team, reporting to the Chief Medical Officer. The SVP will develop and drive regulatory strategies to progress Rocket's innovative pipeline of first-in-class adeno-associated viral vector (AAV) and lentiviral vector (LVV) gene therapies. The ideal candidate will be a dynamic, and astute senior regulatory strategy leader with demonstrated expertise in the rapidly evolving gene therapy industry. This is an opportunity for the successful candidate to make an impact in a critical part of the business. This includes careful evaluation of regulatory and drug development risks or gaps and developing contingency plans with a focus on efficiency and planning for first in human and proof of concept studies through registration. The incoming SVP will be a trusted partner to the leadership team and will be critical to driving Rocket Pharmaceuticals’ development and leadership in regulatory affairs. The SVP of Regulatory Affairs will be responsible for leading and implementing strategic and operational regulatory plans for the development of current and future indications. They will play an important role in maintaining effective communication and fostering critical relationships with internal/external collaborators as well as regulatory authorities. This role provides the unique opportunity to design and guide regulatory pathways across an innovative portfolio of early to pivotal-stage gene therapy assets. As the company continues to scale, the incumbent will have the ability to contribute to the organizational build and directly impact patients’ lives by gaining approval for, and delivering on, critical gene therapy products for rare and undertreated diseases.

  • 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.
  • 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.
  • 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 .
  • First-hand experience with gene therapy products and vaccines is preferred.
  • A leader with a passion for regulatory affairs, science, rare diseases and making a difference in patients’ lives.
  • A regulatory professional that is devoted to life-long learning and elevating the regulatory profession.
  • Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits.
  • In addition to base salary, Rocket offers a competitive total rewards package that may include 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, and a variety of wellness resources and employee support programs.
  • Also, certain positions are eligible for added forms of compensation, such equity awards (long-term incentives).
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