Manager, Regulatory Affairs CMC

Role: Manager, Global Regulatory CMC for Kite’s autologous CAR T-cell therapy portfolio, overseeing global regulatory submissions, lifecycle management, and change management aligned with regulatory strategies. Responsibilities: lead CMC regulatory activities for INDs, BLAs, MAAs, variations; serve as the regulatory lead on cross-functional teams, author and review Module 3 content, develop strategies for process and raw material changes, and support interactions with health authorities. Requirements: Bachelor’s degree plus 6 years or Master’s plus 4 years in regulatory CMC or drug development; strong knowledge of global regulatory requirements (FDA, EMA); experience with biologics or cell/gene therapies, especially autologous CAR-T or ATMPs; excellent communication skills; highly organized and adaptable. High-Value: CAR T-cell therapies, autologous biologics, global regulatory compliance, lifecycle management, IND/BLA/MAA submissions, cross-functional collaboration, innovative cell therapy development. Work Setup: based in Santa Monica, CA with flexibility (2 remote days/week) through 2026, planned relocation to Thousand Oaks, Foster City, or El Segundo by 2027; minimal supervision, fast-paced biotech environment.