Sr Manager, Regulatory Affairs CMC

Role: Senior Manager, Regulatory Affairs CMC, focusing on 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, MAAs, post-approval variations), support lifecycle management, manufacturing site expansion, vector-related changes, and inspection readiness; serve as a cross-functional partner with teams like Tech Ops, Quality, and Manufacturing; contribute to risk mitigation, regulatory responses, and process improvements. Requirements: Bachelor's degree with 8+ years or advanced degrees with relevant industry experience in Regulatory Affairs CMC, specifically in cell therapy/ATMPs; strong knowledge of global regulatory frameworks, ICH guidelines, and GMP practices. Preferred: experience supporting CAR-T or gene therapy products, global filings, lifecycle management, site expansion, and inspection activities; familiarity with vector and manufacturing change assessments. High-Value: expertise in ATMP/CAR-T regulatory requirements, complex manufacturing changes, and global submission strategies; experience with inspection readiness for advanced therapies. Work setup: initially Santa Monica, CA, with planned relocation to Thousand Oaks or El Segundo in 2027; flexible work policy with some remote work; travel not specifically stated.