Associate/Sr. Associate/Manager - Global CMC Regulatory, Regulatory Delivery and Excellence

LI Test Company(1 month ago)

HybridFull TimeMedior$63,000 - $149,600Global Regulatory Affairs

About this role

The Global CMC Regulatory Associate at Eli Lilly supports the operational and technical management of CMC registrations to help expedite delivery of safe and effective drug products worldwide. The role spans CMC records from early clinical trials through marketing withdrawal and works across internal teams and partner companies to ensure regulatory consistency and compliance. The position leverages knowledge of global CMC regulations, electronic submission standards, and regulatory precedents to support lifecycle registration activities.

View Original Listing

Required Skills

CMC Regulatory
CTD Knowledge
Electronic Submissions
Veeva RIM
Project Management
Regulatory Strategy
Cross-Functional
Communication
Negotiation
Problem-Solving

+1 more

Qualifications

Bachelor's Degree (Scientific/Health)

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.

View more jobs at LI Test Company →