Sr Manager, Regulatory Affairs CMC

Role: Senior Manager, Regulatory Affairs CMC, supporting global regulatory activities for Kite’s cell therapy/CAR-T portfolio across clinical and commercial stages. Responsibilities: develop and execute CMC regulatory strategies, prepare and review complex submissions (INDs, BLAs, variations), ensure compliance with global requirements, manage lifecycle activities, support manufacturing site expansions, vector-related changes, and inspection readiness. Serve as a cross-functional partner with Technical Operations, Quality, Manufacturing, and Clinical teams, providing regulatory input on manufacturing changes and site updates, and contribute to continuous improvement initiatives. Requirements: Bachelor's degree with 8+ years (or advanced degree with fewer years) in Regulatory Affairs within biotech/pharma, with strong knowledge of CMC requirements for ATMPs, CAR-T, and GMP. Experience supporting global filings, lifecycle management, and manufacturing changes for complex biologics. Preferred: experience in cell therapy, vector-related regulatory issues, multi-site manufacturing, inspection readiness, and global change management. Skills: cross-functional collaboration, independent work ethic, strategic planning, risk assessment, and strong communication. High-value: expertise in ATMPs, gene therapies, global regulatory strategy, lifecycle management, and process validation for advanced therapies. Work setup: hybrid model, with planned relocation from Santa Monica to Thousand Oaks or El Segundo by January 2027.