Pharmaceutical CMC Regulatory Affairs Subject Matter Expert -AI Model Evaluation
Volga Partners
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Job summary
Volga Partners is seeking experienced CMC Regulatory Affairs professionals for a remote, project-based freelance role evaluating AI-generated pharmaceutical content. Your regulatory judgment and technical expertise help improve AI models without traditional submissions.
You will assess accuracy, compliance, and scientific reasoning, providing structured feedback grounded in FDA, GMP and ICH guidelines. This is a freelance, intermittent opportunity with flexible scheduling.
Qualifications
- Minimum of 4 years of professional experience in CMC Regulatory Affairs.
- Strong knowledge of FDA regulations and ICH guidelines.
- Experience supporting regulatory submissions and lifecycle activities is preferred.
- Excellent written English communication skills and ability to work independently.
Responsibilities
- Evaluate AI-generated pharmaceutical content for accuracy and regulatory compliance.
- Review scientific and manufacturing information related to quality systems, validation, and submissions.
- Analyze AI-generated regulatory reasoning against regulatory expectations and industry best practices.
- Identify errors, inconsistencies, and unsupported claims in content.
- Provide clear expert feedback with recommended corrections and improvements.
- Complete independent evaluations within project timelines using designated platforms.
Skills
Education
Job description
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.
Gain experience contributing to AI evaluation initiatives while leveraging your existing regulatory expertise.
We're looking for professionals who can identify regulatory risks, evaluate compliance considerations, and communicate expert assessments clearly.
Volga Partners offers project-based hourly compensation based on specialization, relevant experience, professional qualifications, geographic location, and assignment requirements.
CMC Regulatory Affairs Subject Matter Experts: $25-$50 USD/hour
Compensation may vary based on experience level, area of expertise, and task complexity.
- Engagement Type: Project-based independent contractor
- Work Arrangement: Remote
- Primary Location: United States preferred
- Additional Markets: Professionals outside the United States may be considered if they possess substantial U.S. pharmaceutical industry experience
- Schedule: Variable and assignment-based
- Project Type: Pharmaceutical AI content evaluation
- Project Duration: Based on project requirements and assignment availability
- Selection Process: Qualified candidates may be required to complete screening questions and evaluation exercises prior to project selection
Specific assignments, schedules, workloads, and project dates will be communicated as they are confirmed. Hours and future assignments are not guaranteed.
If you're an experienced pharmaceutical regulatory professional who enjoys analyzing complex compliance requirements, evaluating technical information, and applying regulatory judgment, we'd love to hear from you.
Join Volga Partners and help shape the next generation of pharmaceutical AI.
We're seeking experienced Regulatory Affairs professionals in the Pharmaceutical world who bring practical industry expertise and are comfortable reviewing technical information, exercising independent judgment, and clearly explaining their conclusions.
- Minimum of 4 years of professional experience in CMC Regulatory Affairs
- Bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Regulatory Affairs, Engineering, or related discipline
- Experience supporting CMC regulatory submissions and lifecycle management activities
- Strong knowledge of FDA regulations and ICH guidelines
- Familiarity with global health authority requirements
- Experience reviewing scientific and manufacturing documentation
- Ability to critically evaluate technical and regulatory information
- Strong analytical, research, and problem-solving skills
- Excellent written English communication skills
- Ability to work independently and follow detailed review instructions
- Comfortable working within a task-based freelance engagement model
We encourage applications from professionals with backgrounds such as:
- RAC certification
- PharmD, MS, MBA, or PhD
- Experience supporting IND, NDA, BLA, ANDA, or MAA submissions
- Global regulatory strategy experience
- Experience responding to health authority questions
- Experience managing post-approval changes and variations
- Technical writing or document review experience
- Familiarity with AI evaluation, data annotation, or quality review activities
Experience with AI model evaluation, large language models (LLMs), research, or structured quality assessments is beneficial but not required.
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