Pharmaceutical CMC Regulatory Affairs Subject Matter Expert – AI Model Evaluation

This is a fully remote position, open to applicants in United States.

📋 Description

• Assess AI-generated pharmaceutical content for precision, thoroughness, consistency, and adherence to industry standards.

• Examine content associated with quality systems, manufacturing, validation, submissions, development, and compliance tasks.

• Evaluate whether AI-generated conclusions are grounded in scientific principles, regulatory requirements, and industry best practices.

• Detect unsupported assertions, technical errors, lack of context, and flawed reasoning.

• Verify information against FDA standards, GMP regulations, ICH guidelines, and established pharmaceutical industry practices.

• Deliver expert feedback, accurate technical corrections, and suggestions for enhancement.

• Implement project-specific evaluation criteria, scoring protocols, and quality benchmarks.

• Conduct independent evaluations using specified online platforms within project deadlines.

⛳️ Requirements

• At least 4 years of professional experience in CMC Regulatory Affairs.

• Bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Regulatory Affairs, Engineering, or a related field.

• Experience in supporting CMC regulatory submissions and lifecycle management processes.

• In-depth knowledge of FDA regulations and ICH guidelines.

• Familiarity with requirements from global health authorities.

• Experience in reviewing scientific and manufacturing documentation.

• Capability to critically assess technical and regulatory information.

• Strong analytical, research, and problem-solving abilities.

• Excellent written communication skills in English.

• Ability to work autonomously and adhere to detailed review instructions.

• Comfortable engaging in a task-based freelance work model.

🏝️ Benefits

• Option to work remotely from an eligible location.

• Flexible, variable schedule based on assignments.

• Project-based work to supplement income.

• Opportunity to engage with cutting-edge AI technologies.

• Experience in contributing to AI evaluation projects.

• No prior AI experience necessary.