Director Regulatory Science and Strategy - LAD
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.
Rocket is seeking a Director Regulatory Science and Strategy - LAD to support the success of our LVV gene therapy programs by serving as the Director, Regulatory Affairs for global regulatory strategy. They will lead and/or supervise IND/CTA and BLA/MAA submissions activities.
Responsibilities:
- Leads and/or serves as part of the core cross-functional team to support BLA filing/submission activities.
- Develops and implements global regulatory strategy (either directly or in conjunction with project teams) to achieve program objectives for complex and/or multiple projects.
- Provide interpretation of regulatory authorities' feedback, policies, and guidelines.
- Serve as the primary liaison with US FDA (and supports EU Regulatory Affairs team with international interactions with regulatory Agencies and Health Authorities).
- Actively participates on multi-disciplinary matrixed project teams to effectively meet project deliverables while adhering to regulatory requirements for programs.
- Proactively engages in the development and monitoring of the global regulatory environment and updating of standards and processes related to regulations.
Responsibilities:
- Minimum BS Degree with 12 years pharmaceutical industry experience – prefer knowledge of biotechnology/gene therapy products, including multi-disciplinary experience, 8+ years of regulatory experience or combination of 6+ years of regulatory and/or related experience (gene/cell therapy experience preferred).
- Extensive experience in the US and International Regulatory Affairs, including practical experience with INDs, BLAs, MAAs, Pediatric Investigation Plans, Orphan Drug designations, rare disease drug development, innovative trial design and/or expedited regulatory pathways.
- Ability to monitor the global regulatory environment, effectively communicate with updating of standards and processes related biologics regulations.
- Experience in interfacing and responding to relevant global regulatory authorities, preferably with respect to gene therapy products.
- Thrive in a fast‐paced environment combining strategic and tactical capabilities.
- Excellent written and verbal communication skills, analytical 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.
