Senior Scientist, Regulatory Affairs-Chemistry, Manufacturing and Control

Role: Senior Scientist (R3) in Regulatory CMC Biologics, leading regulatory strategies and documentation for biological projects throughout development and post-approval. Responsibilities: develop and execute global CMC regulatory plans, manage regulatory submissions (e.g., INDs, BLA, variations), assess risks, and communicate regulatory issues. Requirements: B.S. in a science or engineering field; 5+ years in Regulatory CMC, preferably with biologics or vaccines. Skills: expertise in regulatory compliance, technical documentation (eCTD), and biologics development; strong communication and project management. HighValue: focus on biologics, biologics license applications, global regulatory strategy, compliance, and cross-functional collaboration. WorkSetup: hybrid in the US; no specific travel requirements detailed.