Senior Manager, Regulatory Affairs CMC

Role: Senior Manager, Regulatory Affairs CMC at Fate Therapeutics, focusing on advancing cell therapy products from early development through licensure. Responsibilities: lead global regulatory CMC strategies, author and review submissions (IND, IMPD, BLA, MAA), liaise with health authorities, and collaborate with cross-functional teams (CMC, analytical, quality, research) to ensure high-quality documentation and compliance. Manage CMC change assessments, monitor regulatory developments, and contribute to process improvements. Requirements: Bachelor’s degree in sciences; 7+ years in Regulatory Affairs or CMC within biotech/pharma, with biologics or gene therapy experience preferred. Expertise in global regulations, submission pathways, and familiarity with biologic/cell therapy modalities (e.g., CAR-T, AAV, CRISPR). Strong communication skills, detail orientation, and ability to manage multiple priorities. High-value specifics include expertise in cell therapy development, early to late-stage product registration, and global regulatory interactions. Work setup: full-time, onsite at San Diego headquarters; travel up to 10%.