Regulatory CMC Submission Writer
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Job Summary
To support the evaluation of AI-generated pharmaceutical content, the project-based independent contractor Regulatory CMC Submission Writer Subject Matter Expert will work remotely, assessing the quality and compliance of technical documentation while providing expert feedback to enhance AI model performance.
Key responsibilities
- Evaluate AI-generated pharmaceutical content for accuracy and compliance with regulatory standards
- Review regulatory documentation including CTD/eCTD submissions and related technical data
- Identify errors and inconsistencies in scientific reasoning and documentation quality
Required qualifications
- Minimum of 4 years of experience in Regulatory Writing, CMC Documentation, or Regulatory Affairs
- Bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, or a related field
- Experience with CTD and/or eCTD documentation requirements
- Knowledge of FDA regulations and ICH guidelines
- Strong analytical and technical writing skills
Complete Job Description
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