Sr. Manager- Regulatory Affairs CMC
LI Test Company(7 months ago)
About this role
The CMC RA Senior Manager at Lilly is a regulatory affairs leader focused on chemistry, manufacturing and controls (CMC) for drug products, with a primary emphasis on supporting product registrations and regulatory engagement in China. The role partners closely with cross-functional teams and external authorities to advance regulatory strategy and ensure compliance for marketed and pipeline products.
Required Skills
- CMC
- Regulatory Strategy
- Submission
- Technical Communication
- Negotiation
- Authority Meetings
- Cross-Functional Communication
- Project Support
- English Proficiency
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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