Senior Manager, Regulatory Affairs CMC

Role: Manage regulatory CMC submissions and strategy for Incyte's development and marketed products, covering small molecules and biologics from early to late-stage (phase 3, registration, post-approval). Responsibilities: oversee global CMC submissions, ensure regulatory compliance, liaise with FDA and international agencies, lead or support health authority meetings, review and approve CMC data packages, and manage post-approval change activities. Requirements: degree in a relevant scientific or pharmaceutical field; extensive knowledge of pharmaceutical CMC regulations and drug development; experience with global regulatory submissions, eCTD, and electronic document management; minimum relevant experience in regulatory affairs or pharmaceutical development. Preferred: experience with both large and small molecule drugs, advanced degrees in related fields, and international regulatory experience. HighValue: expertise in CMC regulatory strategy, global health authority interactions, compliance with US and international regulations, and managing documentation for both biologics and small molecules across clinical and post-market phases. WorkSetup: domestic travel up to 10%; location type not specified.