Senior Manager CMC Regulatory Affairs
Company: VirtualVocations
Location: Vista
Posted on: May 24, 2025
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Job Description:
A company is looking for a Senior Manager, CMC Global Regulatory
Affairs.
Key Responsibilities
Provide CMC regulatory strategy input and expertise for biologic
and small molecule drug products
Prepare, coordinate, and review CMC and GMP related documents for
regulatory submissions
Independently manage preparation of INDs, BLAs, CTAs, and
amendments within company timelines
Required Qualifications, Training, and Education
Bachelor's in Pharmaceutical Sciences, Chemistry, or related field;
advanced degrees preferred
7 years of CMC regulatory experience in the pharmaceutical
industry
Comprehensive knowledge of drug development processes and CMC
regulatory requirements
Experience in preparing CMC sections for FDA and equivalent
submissions for Europe and Canada
RAC certification is a plus
Keywords: VirtualVocations, Chula Vista , Senior Manager CMC Regulatory Affairs, Executive , Vista, California
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