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CMC Regulatory Lead

Company: VirtualVocations
Location: Norfolk
Posted on: October 22, 2024

Job Description:

A company is looking for a Lead, Regulatory Affairs CMC.
Key Responsibilities

Develop and execute CMC regulatory strategies for product development
Lead authoring and coordination of regulatory submissions and meeting packages
Serve as the CMC Regulatory Lead on cross-functional project teams

Required Qualifications

Bachelor's degree in life sciences; advanced degree preferred
10+ years of experience in the biotech/pharmaceutical industry
8+ years of regulatory CMC experience
Prior regulatory filing experience with cell or gene therapies preferred
In-depth knowledge of cGMP and global CMC regulatory requirements

Keywords: VirtualVocations, Suffolk , CMC Regulatory Lead, Other , Norfolk, Virginia

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