Director, Regulatory Affairs Advertising, Labeling, and Promotion
Beam TherapeuticsCambridge, Massachusetts, United States
Posted October 15, 2025
Full Time
About the Company
Beam Therapeutics, founded in 2018, is at the forefront of genetic medicine innovation using CRISPR base editing to make precise, permanent edits to DNA without cutting strands. The company focuses on developing advanced gene therapies and precision medicines for treating serious diseases, including rare and genetic disorders. With a team of fearless innovators committed to rigorous research and open collaboration, Beam aims to provide life-long cures through groundbreaking technology.
Job Description
Beam Therapeutics is seeking a Director of Regulatory Affairs – Advertising, Labeling, and Promotion to advance its clinical-stage genetic medicine program. This role involves leading all regulatory labeling activities for hematology programs, creating documentation, negotiating with regulatory agencies, and providing guidance on evolving global regulations. They value innovation and mentoring.
Requirements
- BS (or MS, PharmD, PhD, MD) required
- Minimum 6 years of experience in Regulatory Affairs, ideally 15+ years in biotech with at least 8 in regulatory affairs
- Record of success with regulatory agency interactions
- Comprehensive knowledge of US and global regulatory procedures
- Experience with regulatory documents and filings (IND, CTA/IMPD, BLA, MAA, PIP)
