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...
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...