Manager, Regulatory Affairs CMC
Scorpion Therapeutics
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; 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. #J-18808-Ljbffr Scorpion Therapeutics
Vacancy posted 3 days ago
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