Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These... submissions include health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC...
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These... submissions include health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC...
and site staff. Interfaces with cross-functional teams (e.g. Medical Monitor, Regulatory Affairs, CMC/Supply Chain, CRO... Trial Manager will oversee the planning, execution, and management of clinical studies to ensure compliance with protocols...
Brand Team, CMC, Integrated evidence strategy team, Value and Access team, Regulatory strategy, etc.). Ensure..., Market Access, Regulatory, Safety, Project Management, Medical Affairs, etc., and substantial cross-functional interaction...