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CMC Regulatory Affairs Project Manager
Job is Expired
Location: Nationwide
Compensation: Hourly
Reviewed: Thu, Sep 28, 2023
Job Summary
A company is looking for a CMC Regulatory Affairs Project Manager.
Key Responsibilities:
- Develop CMC regulatory strategies and contingency plans for biologic and small molecule drug products
- Determine regulatory requirements for CMC and GMP submissions
- Prepare and review CMC and GMP documents for regulatory authorities
Required Qualifications:
- 5-7 years of CMC regulatory experience in the pharmaceutical industry
- Comprehensive knowledge of drug development process, GMP, and regulatory requirements for biologics and small molecules
- Experience preparing CMC sections for FDA and equivalent submissions
- Bachelors in Pharmaceutical Sciences or Chemistry, or related field
- RAC certification is a plus
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Job is Expired
