CMC Regulatory Affairs SME
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Job Summary
Seeking experienced CMC Regulatory Affairs professionals, the part-time independent contractor will evaluate AI-generated pharmaceutical content remotely, assessing accuracy, completeness, and regulatory compliance while providing expert feedback to enhance AI model performance.
Key responsibilities
- Evaluate AI-generated pharmaceutical content for accuracy and compliance with industry standards
- Review scientific and regulatory information related to quality systems and compliance activities
- Provide expert feedback and recommendations to improve AI-generated regulatory content
Required qualifications
- Minimum of 4 years of professional experience in CMC Regulatory Affairs
- Bachelor's degree or higher in a relevant discipline such as Pharmacy or Regulatory Affairs
- Strong knowledge of FDA regulations and ICH guidelines
- Experience supporting CMC regulatory submissions and lifecycle management activities
- Ability to critically evaluate technical and regulatory information
Complete Job Description
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