Senior Scientist, Regulatory Affairs-Chemistry, Manufacturing and Control

Role: Senior Scientist (R3) in Regulatory CMC Biologics, serving as project lead to develop and execute global regulatory strategies for biologics. Responsibilities include managing CMC documentation (INDs, BLAs, variations), ensuring compliance, and assessing regulatory risks across product lifecycle stages. Requirements: BS in a science or engineering field (advanced degree preferred), 5+ years in Regulatory CMC, with biologics experience strongly preferred. Core skills encompass regulatory affairs management, documentation, compliance, and communication with health authorities, with proficiency in electronic submissions (eCTD). High-value biopharma specifics include biologics, vaccine development, regulatory submissions, and post-approval lifecycle management. Collaboration involves cross-functional teams within regulatory and development units. Work setup is hybrid, based in the US, with some travel expected.