Director, CMC Regulatory

LI Test Company(1 month ago)

United States, Philadelphia, PAOnsiteFull TimeDirector$148,500 - $217,800Regulatory Affairs

About this role

The Director, CMC Regulatory at Lilly leads global chemistry, manufacturing and controls (CMC) regulatory strategy for Lilly | Avid diagnostic radiopharmaceutical products. The role focuses on delivering global CMC regulatory submissions and providing regulatory science expertise across regions to support investigational and commercial products.

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Required Skills

CMC Regulatory
Regulatory Strategy
Submissions
Technical Writing
Team Management
Change Control
Regulatory Intelligence
Communication
Leadership
MS Office

Qualifications

BS Degree in Science or Engineering
Advanced Degree (Preferred)

About LI Test Company

lilly.com

Eli 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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