Manager, Regulatory Affairs

Role: Manager, Regulatory Affairs, supports global regulatory submissions for investigational and marketed biologics, primarily in cell therapy. Responsibilities include managing INDs, BLAs, amendments, preparing documentation, and maintaining regulatory dossiers. The role involves cross-functional collaboration, ensuring compliance with international regulations like ICH, and 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, and regulatory strategy development. Preferred: advanced degree. High-Value: biologics, cell therapy, regulatory submissions for INDs/BLAs, international regulatory knowledge, GxP, and document management expertise. Work setup: remote; physical and mental demands consistent with office work.