Associate Director, Regulatory CMC
LI Test Company(1 month ago)
About this role
Associate Director, Regulatory CMC at Verve Therapeutics (Eli Lilly) supports regulatory aspects of CMC for gene-editing and biologics programs aimed at treating cardiovascular disease. The role partners with cross-functional teams and external vendors to align regulatory strategy with manufacturing and development across the product lifecycle. This position is based in Boston, MA.
Required Skills
- CMC Strategy
- Regulatory Submissions
- Health Authorities
- IND Filings
- BLA Filings
- cGMP
- Cross-Functional
- Project Management
- Document Authoring
- Quality Assurance
Qualifications
- BS Degree in Relevant Scientific Discipline
- Advanced Degree Preferred
About LI Test Company
lilly.comEli Lilly and Company is a global biopharmaceutical company headquartered in Indianapolis, Indiana. It discovers, develops, manufactures and commercializes prescription medicines across therapeutic areas including diabetes, oncology, immunology, neuroscience and pain, and has a longstanding history in insulin and other major drug discoveries. Lilly invests heavily in research and clinical development and partners with biotech, academic institutions, and industry collaborators to advance biologics, small molecules, and precision medicines. The company operates global manufacturing and commercial networks and provides patient-support programs to improve access to its therapies.
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