Pharmaceutical CMC Regulatory Affairs Subject Matter Expert -AI Model Evaluation

Remote | United States | Project-Based Independent Contractor

Compensation: $20-$50 USD/hour, based on specialty, experience, and project requirements

What if your expertise in Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs could help artificial intelligence better understand global pharmaceutical regulations, submission requirements, and product lifecycle management?

At Volga Partners
, we're connecting experienced pharmaceutical professionals with opportunities to contribute to the development and evaluation of advanced AI models.

We're seeking experienced CMC Regulatory Affairs professionals who can apply their regulatory expertise, scientific judgment, and industry knowledge to evaluate AI-generated pharmaceutical and regulatory content.

This isn't a traditional position. You won't be preparing submissions, managing product registrations, or interacting with health authorities. Instead, you'll evaluate complex regulatory content, identify technical inaccuracies, assess regulatory reasoning, and provide structured feedback that improves AI model performance.

Your pharmaceutical expertise is what matters. AI experience is a plus, not a requirement.

Important Note:

This is a freelance, task-based role designed for those seeking supplemental income. It’s essential to understand the nature of freelance work—tasks will be assigned as they become available, and work may be irregular or intermittent.

As a CMC Regulatory Affairs Subject Matter Expert (SME), you'll serve as a subject matter evaluator, helping assess the quality, accuracy, completeness, and regulatory compliance of Pharmaceutical AI-generated content.

You'll analyze scientific, regulatory, manufacturing, and compliance-related scenarios, identify errors or unsupported conclusions, and provide expert feedback grounded in industry standards, regulatory frameworks, and professional judgment.

Your contributions will help improve how AI systems understand and respond to complex pharmaceutical and biotechnology challenges.

• Evaluate AI-generated pharmaceutical content: Assess scientific, technical, and regulatory responses for accuracy, completeness, consistency, and compliance with industry standards.
• Review scientific and regulatory information: Examine content related to quality systems, manufacturing, validation, submissions, development, and compliance activities.
• Analyze technical reasoning: Determine whether AI-generated conclusions are supported by relevant scientific principles, regulatory expectations, and industry best practices.
• Identify errors and inconsistencies: Recognize unsupported claims, technical inaccuracies, missing context, and flawed reasoning.
• Validate information: Reference relevant FDA requirements, GMP regulations, ICH guidelines, and accepted pharmaceutical industry practices.
• Provide expert feedback: Clearly explain findings, identify opportunities for improvement, and recommend technically accurate corrections.
• Support AI quality improvement: Apply project-specific evaluation criteria, scoring guidelines, and quality standards.
• Complete independent evaluations: Use designated online platforms to complete assignments accurately and within established project timelines.

Use the knowledge you've developed throughout your regulatory affairs career to contribute to advanced AI technologies.

Your expertise will help strengthen the quality and reliability of AI-generated regulatory content.

Participate in project-based assignments from an eligible location, with flexibility based on project availability.