VP, Regulatory Affairs

Role: Vice President of Regulatory Affairs at Prime Medicine, responsible for developing and executing global regulatory strategies for gene editing, cell therapy, and combination products across early to late-stage development. Responsibilities: serve as primary regulatory interface with agencies like FDA (CBER/CDER) and EMA; lead IND/CTA, BLA/MAA submissions; manage regulatory risk assessments; oversee interactions with health authorities, including expedited pathways such as Breakthrough Therapy and RMAT; guide cross-functional teams (Research, CMC, Clinical, Manufacturing) on regulatory readiness and compliance; monitor evolving regulatory guidance for advanced therapies; manage external consultants and CROs. Requirements: Bachelor’s in a scientific discipline; advanced degree (PhD, PharmD, MD) preferred; 15+ years in regulatory affairs within biotech or pharma, with leadership experience; deep expertise in gene therapy, gene editing, cell therapy, or ATMPs; proven success in global submissions, including complex novel modalities; strong experience with regulatory agencies, especially FDA CBER; familiarity with regulatory pathways for rare diseases and expedited programs. Skills: strategic thinking, hands-on approach, leadership, negotiation, cross-functional influence, ability to manage multiple programs, entrepreneurial mindset, willingness to travel. High-value biopharma specifics include focus on gene editing platforms, advanced medicinal therapies, and global regulatory market engagement in the US and EU. Location: US-based, flexible work setup; travel as needed.