Associate / Sr. Associate - Regulatory CMC, Regulatory Delivery Excellence (RDE)

LI Test Company(26 days ago)

HybridFull TimeMedior$111,700 - $148,065 (estimated)Regulatory Affairs

About this role

The Associate, Regulatory CMC (12-month fixed-term) at Eli Lilly Cork supports global regulatory activities for CMC submissions, helping ensure timely marketing authorizations and product lifecycle maintenance. The role partners across regulatory scientists, affiliates, and quality representatives to manage submission content and align documentation with global regulatory standards. It is based at the Little Island Cork campus with flexible hybrid working options.

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Required Skills

CMC
CTD
Electronic Submissions
Regulatory Strategy
Project Management
Communication
Negotiation
Teamwork
Problem Solving
Detail Orientation

Qualifications

Bachelor’s Degree in a Scientific or Health Sciences Discipline

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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