Manager, Regulatory Delivery Excellence, China Regulatory Affairs
LI Test Company(2 months ago)
About this role
The Associate/Manager, Regulatory Delivery Excellence (China Regulatory Affairs) at Lilly supports regulatory registration management and submission preparation for medicines in China, covering activities from clinical trial permits through marketing application lifecycle. The role sits in the China Regulatory Affairs organization and partners with global and local stakeholders to ensure regulatory compliance and accurate regulatory records in RIM systems. This position requires a background in pharmaceutical or chemical/biopharmaceutical sciences and relevant regulatory or drug development experience.
Required Skills
- Regulatory Submissions
- Submission Planning
- RIM Systems
- Veeva Vault
- Document Formatting
- QC Testing
- Vendor Management
- Translation Management
- Cross-Functional Collaboration
- English Communication
Qualifications
- Bachelor's Degree in Pharmaceutical or Chemical/Biopharmaceutical Sciences
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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