Senior Director/Director, Regulatory Affairs CMC

Role: Regulatory CMC Lead/Sr. Director for Beam Therapeutics' innovative gene editing therapies, focusing on global regulatory strategy and compliance for cell and gene therapies. Responsibilities: develop and communicate CMC regulatory strategies, lead preparation of high-quality global submissions (IND/CTA/MF and BLA/MAA), provide expert guidance on manufacturing, analytical, and supply chain strategies, review scientific data for regulatory documents, evaluate change proposals, and facilitate interactions with health authorities. Qualifications: BA/BS in a scientific or engineering field with 15+ years' industry experience, including 10+ years in regulatory CMC or related functions; extensive knowledge of FDA, EMA, ICH guidelines; proven experience with biologics, cell therapies, or lipid nanoparticles; strong technical writing, organizational, and communication skills; experience with CTD format and global filings. Preferred: background in biologics, cell therapy, and international submissions. Work setup: onsite 1-3 days/week, with global regulatory responsibilities in a pioneering biotech setting.