CMC RA Senior Manager China submissions

The Senior Manager will lead the preparation of CMC documentation for China submissions for large molecule therapeutic drug candidates, from clinical development through post-approval stages. This includes leading CDE consultation meetings, preparing scientific briefing and response documents, and managing the lifecycle of China dossiers. The role involves assessing the regulatory impact of CMC change controls, strategizing variation filings, ensuring submission package compliance, overseeing local QC testing, coordinating with partners, providing strategic input into CMC development, and tracking regulatory commitments.