Senior Associate, Regulatory CMC

Role: Senior Associate, Regulatory CMC supporting biopharma biologics and cell therapy products, with focus on strategy, compliance, and submissions. Responsibilities: prepare/review regulatory documents (IND, IMPD, BLA, MAA), manage regulatory systems, develop long-term CMC strategies, support FDA and international inspections, ensure compliance with 21 CFR Part 1271 and global regulations, and collaborate with Quality, Manufacturing, and R&D teams. Requirements: minimum 5 years in biotech/pharmaceutical industry, with 1-2 years in Regulatory Affairs preferred; proven experience in CMC submissions for biologics, cell therapies, and device combinations; strong knowledge of ICH GxP, product lifecycle management, and international regulatory standards. HighValue: biologics and cell therapy focus, late-stage clinical or commercial development, FDA RMAT and Fast Track designations, expertise in aseptic processing, human tissue regulations, and international submissions (especially Europe). WorkSetup: Fully remote in Durham, NC area; no travel specified.