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Global CMC Regulatory Associate at Eli Lilly and Company - ApplyBlast

Global CMC Regulatory Associate

Eli Lilly and Company

23 days ago

4.0 on Glassdoor

Cork, Ireland

Hybrid

Full Time

Junior

0 applicants

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About this role

The Global CMC Regulatory Associate supports the operational and technical CMC registration management processes to expedite the delivery of safe and effective products to patients globally. This role involves managing CMC submissions from clinical trials through marketing application withdrawal, ensuring compliance with global regulations and ICH CTD standards. The associate collaborates with cross-functional teams to drive submission planning, strategy development, and project management for product lifecycle maintenance.

Responsibilities

Lead CMC submission management process and prepare CTD content
Partner with CMC RA Scientists to plan and prepare submission content
Coordinate submissions with RD&E specialists and manage project timelines

Skills

Qualifications

Bachelor's Degree in a scientific or health sciences field

About Eli Lilly and Company

lilly.com

Headquarters

Indianapolis, Indiana, United States

Company Size

10001+ employees

Founded

1876

View Profile

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.