$210,000–$300,000/yr
US
4w PTO
- Serve as CMC regulatory expert, developing global submission strategies and assessing regulatory risks for development and commercial programs.
- Lead preparation and review of CMC submission content including CTD Module 2 and Module 3 sections, and support regulatory filings from IND to MAA.
- Guide CMC lifecycle management, regulatory authority interactions, and monitor emerging regulations to inform client strategies.