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Senior Director, Regulatory CMC at Eli Lilly and Company - ApplyBlast

Senior Director, Regulatory CMC

Eli Lilly and Company

5 days ago

4.0 on Glassdoor

Remote

Full Time

Director

0 applicants

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About this role

The Senior Director, Regulatory CMC provides strategic and operational leadership for Regulatory CMC activities across small molecule development programs at Centessa Pharmaceuticals. This role involves developing global CMC regulatory strategies, overseeing regulatory submissions, and partnering with internal and external stakeholders to drive regulatory readiness. The position requires extensive experience in late-stage development, NDA-enabling activities, and managing outsourced development and manufacturing.

Responsibilities

Develop and execute integrated Regulatory CMC strategies for small molecule programs
Lead preparation and approval of CMC content for global regulatory submissions
Manage external development and manufacturing partners including CDMO selection and oversight

Skills

Qualifications

Master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific disciplinePharmDPhD

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.