Director, Drug & Device Combo (Autoinjector/Inhalation) Reg.-CMC (Remote)

Job description

Job Description Director/Principal Scientist, Devices and Drug-Device Combinations Regulatory CMC Reporting to the Director of Device Regulatory Affairs for Autoinjector Development Programs, the Director/Principal Scientist in Devices and Drug-Device Combinations CMC is responsible to support Device CMC regulatory activities for Our Company’s autoinjector, inhalation, and other delivery system products in accordance with global regulations and guidelines and is responsible for technical content input and coordination of CMC submissions for all assigned activities. Product responsibilities may be in the small molecules, biologics or vaccines portfolio, and could be in the development or the marketed product phase of a drug product life cycle. Responsibilities: Lead Device Regulatory Affairs strategies for autoinjector, inhalation, and other delivery system development programs by ensuring robust assessment of scientific content and critical evaluation of supporting regulatory documentation to confirm acceptability and identification of potential risks. Support the drug-led CMC Product Team on assigned products and be accountable for the delivery of all assigned regulatory activitie...