Vice President, Regulatory Science and Strategy, Franchise Head AAV
Cranbury, NJ
Regulatory – Regulatory Affairs /
Full Time /
Hybrid
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.
Make a difference in patients’ lives one submission at a time!
Rocket’s Regulatory organization provides unmatched expertise related to global regulatory activities through all stages of a product’s lifecycle and is at the forefront of shaping a dynamic regulatory landscape in gene therapy. Today’s work at Rocket will create a roadmap for future gene therapy approvals in the years to come. Rocket’s pipeline of first-in-class therapies and numerous expedited review designations yields more opportunities to interact with health authorities and build collaborative relationships. This dedicated organization features some of the best talent in the world and is guided by delivering curative gene and cell therapies for rare and devastating diseases.
Rocket is seeking a Vice President, Regulatory Affairs to support the success of our AAV and LVV gene therapy programs by providing regulatory oversight for regulatory activities across the product lifecycle, from development through post-approval, while overseeing department activities and cross-functional teams. This person will also oversee our interactions with FDA, EMA, and other global regulatory agencies. To be successful in this role, you must be able to provide sound strategic regulatory guidance, communicate clearly (in verbal and written form), and display exemplary organizational / leadership skills. In addition, the successful candidate will create an environment in which the team is highly motivated and engaged to work collaboratively within their team and cross functionally to deliver exceptional results and ensure long-term success.
Responsibilities:
- Work closely with the executive leadership team to lead the development of regulatory strategies and objectives that result in the successful registration and post-approval commercialization of Rocket’s products and product-candidates.
- Develop and implement operational plans to achieve board-approved regulatory objectives.
- Serve as primary regulatory agency contact (at the FDA and at other agencies) to achieve company regulatory objectives, by fostering strong relationships and acting as a credible, reputable, and effective advocate for Rocket.
- Serve as key point of contact for managing and directing regulatory inspections.
- Keep peers and superiors apprised of expected changes to the regulatory landscape affecting existing and future Rocket products and provide strategic and tactical direction to drive cross-discipline consistency in regulatory approach and planning.
- Facilitate strategies for the approval of products in rest-of-world regions either by Rocket or by its partners/affiliates, and act as the senior regulatory contact for ongoing alliance management activities.
- Develop and design robust regulatory structures, processes and procedures, and budget forecasting based on expert understanding, industry experience, and insight into the future direction of regulatory policy.
- Partner with and support clinical development, CMC, preclinical, quality, medical affairs, commercial and corporate activities, including the review and submission of clinical protocols and regulatory documents, publications, investor relations/legal public disclosures throughout the product life cycle.
- Provide the business development team with guidance and critical evaluation of potential product opportunities, in support of strategic partnering and licensing activities.
- Provide regulatory review and approval of product labeling, promotional claims, and advertising to ensure compliance with corporate policy, and US and international laws and regulations.
- Direct long and short-term departmental planning including structure, headcount, budgeting, training, and systems requirements.
- Manage internal regulatory procedures to ensure compliance.
- Manage external regulatory vendor and platform service team members and providers.
- Hire, onboard and manage regulatory professionals.
Education/Experience and Skills Requirements:
- Minimum BA/BS Degree with 15+ years Pharmaceutical industry experience – prefer knowledge of biotechnology / gene therapy products, including multi-disciplinary experience, with 10 years CMC regulatory strategy (gene/cell therapy experience preferred).
- Experience in interfacing and responding to relevant global regulatory authorities, especially with respect to gene therapy products.
- Knowledge and understanding of US and international regulations and ICH guidelines related to CMC gene therapy development.
- Experience and knowledge in the preparation of CMC content for major global regulatory submissions including INDs, CTAs, license applications, and meeting briefing packages.
- Thrive in a fast‐paced environment combining strategic and tactical capabilities.
- Excellent written and verbal communication skills, analytic and problem-solving.
A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.
