Regulatory CMC Submission Writer 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 regulatory writing, CMC documentation, and global pharmaceutical submissions could help artificial intelligence better understand regulatory requirements, technical documentation standards, and submission best practices?

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 Regulatory CMC Submission Writers who can apply their regulatory writing expertise, scientific knowledge, and technical documentation experience to evaluate AI-generated pharmaceutical and regulatory content.

This isn't a traditional regulatory writing position. You won't be authoring submissions for health authorities, coordinating submission timelines, or supporting active filing activities. Instead, you'll evaluate complex regulatory and scientific content, identify technical inaccuracies, assess document quality and 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 Regulatory CMC Submission Writer 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 regulatory, scientific, manufacturing, analytical, and technical documentation scenarios, identify errors or unsupported conclusions, and provide expert feedback grounded in established submission standards, regulatory requirements, and industry best practices.

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

• Evaluate AI-generated pharmaceutical content: Assess scientific, technical, and regulatory responses for accuracy, completeness, consistency, and compliance with submission requirements.
• Review regulatory documentation: Examine content related to CTD/eCTD submissions, Module 3 documentation, manufacturing information, analytical data, validation summaries, and stability reports.
• Analyze technical reasoning: Determine whether AI-generated conclusions are supported by scientific evidence, regulatory expectations, and accepted documentation practices.
• Identify errors and inconsistencies: Recognize unsupported claims, technical inaccuracies, documentation deficiencies, missing context, and flawed regulatory reasoning.
• Validate information: Reference FDA requirements, ICH guidelines, CTD standards, and accepted pharmaceutical industry practices.nt 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.

Apply Your Industry Expertise in a New Way
Use the knowledge you've developed throughout your pharmaceutical…