Associate Director, Regulatory CMC
Company: VirtualVocations
Location: Vista
Posted on: May 21, 2025
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Job Description:
A company is looking for an Associate Director, Regulatory
CMC.
Key Responsibilities
Collaborate with cross-functional teams to plan, write, and review
CMC sections of regulatory submissions
Provide regulatory guidance on Module 2/Module 3 content and assess
proposed CMC changes for regulatory impact
Communicate with regulatory Health Authorities and ensure alignment
with current regulations and industry guidance
Required Qualifications
B.S. in a scientific discipline required; advanced degree
preferred
At least 8 years of experience in CMC Regulatory Affairs within the
pharmaceutical industry
Demonstrated leadership in regulatory submissions and effective
project management
Strong knowledge of cGMP, biologics drug development regulations,
and eCTD structure
Experience leading interactions with health authorities and
managing multiple projects
Keywords: VirtualVocations, Fullerton , Associate Director, Regulatory CMC, Executive , Vista, California
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