Director Regulatory Science, CMC Health Authority Liaison
Cranbury, NJ /
Regulatory – Regulatory Affairs /
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.
Rocket is seeking a Director, Regulatory Affairs – CMC to support the success of our LVV gene therapy programs by serving as the global product leader for CMC regulatory strategy. They will proactively manage multiple Regulatory CMC projects by coordinating with both internal and external stakeholders. They will formulate and implement global CMC regulatory strategies for the development of gene therapy programs that are in line with global requirements and coordinate all aspects of CMC regulatory submissions relevant to assigned projects or programs.
- Develop and execute a global Regulatory-CMC strategy for Rocket’s gene therapy products from early development to licensure.
- Lead the preparation and review of CMC submission documents, registration dossiers, and responses to health authorities with other relevant functions. Submissions include health authority briefing packages/IND/IMPD/BLA and MAA regulatory filings.
- Serve as the CMC Regulatory lead in Health Authority interactions and meetings.
- Work with cross-functional CMC, analytical, quality and regulatory teams to create high-quality submissions.
- Represent CMC regulatory strategy at cross-functional Global Project Team, Change Management team and relevant governance meetings.
- Minimum BS Degree with 12 years Pharmaceutical industry experience – prefer knowledge of biotechnology / gene therapy products, including multi-disciplinary experience, 7+ 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, EU, 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.
Full COVID-19 vaccination is required for employment at Rocket Pharmaceuticals.