Regulatory Compliance Auditor Subject Matter Expert -AI Model Evaluation
Volga Partners
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Job summary
Volga Partners is seeking experienced Regulatory Compliance Auditors to evaluate AI-generated pharmaceutical content. This is a remote, project-based freelance role based in the United States, with compensation of $25-$50 per hour depending on specialty and experience.
You will assess scientific, regulatory, and quality information, identify errors, and provide expert feedback aligned with FDA requirements, GMP, ICH guidelines, and industry best practices.
Qualifications
- Minimum of 4 years of professional experience in Regulatory Compliance, Quality Auditing, GMP Auditing, Supplier Quality, Quality Assurance, or related pharmaceutical functions.
- Bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Engineering, Life Sciences, Regulatory Affairs, or a related discipline.
Responsibilities
- 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.
Skills
Education
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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 pharmaceutical auditing, regulatory compliance, quality systems, and inspection readiness could help artificial intelligence better understand compliance risks, regulatory expectations, and audit 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 Compliance Auditors who can apply their auditing expertise, compliance knowledge, and industry experience to evaluate AI-generated pharmaceutical content.
This isn't a traditional auditing position. You won't be conducting supplier audits, preparing organizations for regulatory inspections, or managing compliance programs. Instead, you'll evaluate complex compliance and audit-related 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 Regulatory Compliance Auditor 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 auditing, quality, manufacturing, compliance, supplier oversight, and inspection-readiness scenarios, identify errors or unsupported conclusions, and provide expert feedback grounded in regulatory requirements, audit principles, and pharmaceutical industry best practices.
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.
Apply Your Industry Expertise in a New Way
Use the knowledge you've developed throughout your pharmaceutical or biotechnology career to contribute to advanced AI technologies.
Help Improve Scientific Accuracy
Your evaluations will help strengthen the quality and reliability of AI-generated pharmaceutical and regulatory information.
Work Remotely
Participate in project-based assignments from an eligible location, with flexibility based on project needs and availability.
Explore the Future of Pharmaceutical Technology
Gain experience contributing to AI evaluation initiatives while applying your existing scientific and regulatory expertise.
No AI Background Required
We're looking for professionals who can recognize accurate scientific reasoning, identify errors, and communicate expert assessments with clarity.
Volga Partners offers project-based hourly compensation based on specialization, relevant experience, professional qualifications, geographic location, and assignment requirements.
Regulatory Compliance Auditor 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 or biotechnology professional who enjoys analyzing complex scientific information, applying regulatory and technical expertise, and contributing to innovative technology, 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 Regulatory Compliance, Quality Auditing, GMP Auditing, Supplier Quality, Quality Assurance, or related pharmaceutical functions
- Bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Engineering, Life Sciences, Regulatory Affairs, or a related discipline
- Experience conducting or participating in GMP audits, supplier audits, compliance inspections, or quality system assessments
- Strong knowledge of FDA regulations, GMP requirements, and relevant ICH guidelines
- Experience evaluating quality systems, compliance programs, and corrective action plans
- Familiarity with audit planning, execution, reporting, and CAPA verification activities
- Experience reviewing quality, manufacturing, laboratory, or regulatory documentation
- Ability to critically evaluate technical and compliance-related 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:
- Lead Auditor certification or equivalent auditing credentials
- PharmD, MS, MBA, PhD, or other advanced scientific credentials
- Experience conducting supplier, contract manufacturer, or third-party audits
- Experience supporting FDA, EMA, MHRA, Health Canada, or international regulatory inspections
- Experience leading compliance remediation and CAPA effectiveness programs
- Knowledge of GMP, GDP, GLP, and GCP requirements
- Experience performing risk-based auditing and compliance gap assessments
- Experience evaluating Quality Management Systems (QMS)
- Experience collaborating with Manufacturing, Quality Assurance, Regulatory Affairs, Validation, and Technical Operations teams
- Experience with technical writing, audit reporting, or compliance documentation review
- 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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