Manager, Regulatory Affairs

Role: Manager, Regulatory Affairs, supporting global CMC regulatory activities for allogeneic gamma delta T cell therapies in early to late-stage clinical development. Responsibilities: manage CMC regulatory strategies, prepare and file regulatory submissions, author and review documentation, support agency meetings (e.g., FDA pre-IND, EOP), and ensure compliance with GxP and evolving regulations. Requirements: BA/BS in life sciences or related field; 8+ years in Regulatory Affairs with at least 5 years in CMC; experience with FDA and ex-US submissions; strong scientific background; knowledge of INDs, CTAs, DMFs, and amendments. Preferred: advanced degree; experience in biotech/pharma quality, analytical testing, manufacturing, or research. HighValue: cell therapy (gamma delta T), early to late clinical stages, global regulatory strategy, GxP compliance, cross-functional collaboration. Work setup: onsite at least three days/week (Tue–Thu), some roles full-time onsite; located in a state-of-the-art facility.