Manager, Regulatory Affairs
Scorpion Therapeutics
Role Manager, Regulatory Affairs, supports global regulatory submissions for investigational and marketed biologics, primarily in cell therapy. Responsibilities managing INDs BLAs amendments preparing documentation maintaining regulatory dossiers cross-functional collaboration ensuring compliance with international regulations like ICH developing submission strategies Requirements BA/BS 8+ years in regulatory affairs or related drug/biologic development experience with global electronic submissions (eCTD) regulatory agency interactions regulatory strategy development Preferred advanced degree High-Value biologics cell therapy regulatory submissions for INDs/BLAs international regulatory knowledge GxP document management expertise Work setup remote; physical and mental demands consistent with office work. #J-18808-Ljbffr Scorpion Therapeutics
Vacancy posted 2 days ago
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