Associate Director, Regulatory Affairs
Company: VirtualVocations
Location: Vista
Posted on: May 24, 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, with
direct experience in development programs through registration
Demonstrated leadership in regulatory submissions and effective
project management
Strong knowledge of cGMP and drug development regulations,
including ICH, FDA, and EMA guidelines
Experience with eCTD elements and leading interactions with health
authorities
Keywords: VirtualVocations, Alhambra , Associate Director, Regulatory Affairs, Executive , Vista, California
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