The Regulatory CMC lead is responsible for overseeing and managing all aspects of regulatory affairs related to chemistry, manufacturing, and controls - Warrenton, United States - SilverTech

SilverTech

Verified Company

Warrenton, United States

3 weeks ago

Posted by:

Meredith Sinclair

beBee Recruiter

Description

This well-respected leader in the pharmaceutical and biotechnology industry is currently seeking a highly accomplished Senior Manager of Regulatory CMC to join their established and dynamic team in Warrenton. This individual will play a crucial role in supporting clients with navigating the complex process of developing new molecules.

The ideal candidate for this role will be an experienced professional who thrives on working on a diverse range of projects and molecules.

Key Responsibilities:

Provide guidance on Regulatory CMC strategies for global projects at various stages of development
Manage interactions with health authorities (EMA/FDA) for information requests, briefing books, and IMPDs
Advise project teams on CMC requirements, issues, and potential solutions

Experience Required:

At least 5 years of industry experience in Regulatory CMC
Hands-on experience with EMA or FDA
Demonstrated ability to produce high-quality CMC documentation for complex molecules, including biologics
Experience with CMC development activities
Fluency in English is essential, knowledge of other languages is a plus
Ability to thrive in a dynamic company environment