VP, Regulatory Affairs
Prime Medicine · Cambridge, MA
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Prime Medicine seeks a Vice President of Regulatory Affairs to lead global regulatory strategy for a diverse pipeline of gene editing and advanced therapy programs. The role involves directing submissions to health authorities, managing regulatory compliance, and building a high-performing regulatory team while partnering across research, clinical, and manufacturing functions.
Where this listing comes from
This listing was compiled by RoleLantern from the employer's publicly available posting on Greenhouse, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-04 (originally posted 2026-10-03). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.
What they're looking for
- Extensive experience in regulatory affairs for gene therapies or advanced medicinal therapy products
- Demonstrated expertise managing FDA and EMA interactions for IND, CTA, BLA, and MAA submissions
- Strategic leadership experience building and mentoring regulatory affairs teams
- Deep knowledge of expedited pathways including Breakthrough Therapy and RMAT designations
- Track record navigating regulatory strategy for multiple therapeutic modalities and clinical development stages
- Executive-level communication skills for Board-level and cross-functional leadership engagement
What you'll be doing
- Develop and execute global regulatory strategies for gene editing, cell therapy, and combination product programs
- Serve as primary regulatory contact with FDA, EMA, and international health authorities for all submissions and negotiations
- Oversee preparation and quality assurance of IND, CTA, BLA, and MAA filings across US, EU, and global regions
- Lead regulatory risk assessment and mitigation planning across entire clinical pipeline
- Build and mentor regulatory affairs team while partnering with CMC, clinical, nonclinical, and manufacturing functions
Privacy & handoff
This role links to Prime Medicine's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.