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Volga Partners

Enterprise AI engineering and operational platform

Pharmaceutical CMC Regulatory Affairs Subject Matter Expert

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeRemote in USA$25 - $50 /hr

About the Job

Requirements

  • A minimum of 5 years of professional experience in Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs.
  • A bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Regulatory Affairs, Engineering, or a related discipline.
  • Experience supporting CMC regulatory submissions and lifecycle management activities.
  • Strong knowledge of Food and Drug Administration (FDA) regulations and International Council for Harmonisation (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.
  • Comfort working within a task-based freelance engagement model.

Responsibilities

  • Evaluate AI-generated pharmaceutical content for accuracy, completeness, consistency, and compliance with industry standards.
  • Review scientific and regulatory information related to quality systems, manufacturing, validation, submissions, development, and compliance activities.
  • Analyze whether AI-generated conclusions are supported by scientific principles, regulatory expectations, and industry best practices.
  • Identify unsupported claims, technical inaccuracies, missing context, and flawed reasoning.
  • Validate information by referencing relevant FDA requirements, Good Manufacturing Practice (GMP) regulations, ICH guidelines, and accepted pharmaceutical industry practices.
  • Explain findings, identify opportunities for improvement, and recommend technically accurate corrections.
  • Apply project-specific evaluation criteria, scoring guidelines, and quality standards to support AI quality improvement.
  • Complete independent evaluations using designated online platforms accurately and within established project timelines.

Desired Qualifications

  • Registered in the Association of Clinical Research Professionals (RAC) certification.
  • PharmD, Master of Science, Master of Business Administration, or PhD.
  • Experience supporting Investigational New Drug (IND), New Drug Application (NDA), Biologics License Application (BLA), Abbreviated New Drug Application (ANDA), or Marketing Authorisation Application (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, research, or structured quality assessments.

About the Company

Volga Partners

Enterprise AI engineering and operational platform

Volga Partners provides enterprise AI engineering and a proprietary Volga AI Platform to help large organizations build and operationalize AI solutions. The Volga AI Platform accelerates AI adoption while keeping clients’ data, models, and IP under their control, and includes AI optimization, multilingual training data in 150+ languages, human evaluation and labeling, document intelligence, and agentic AI training environments, delivered through onsite, onshore, and offshore partnerships to ensure secure, scalable deployments. It differentiates itself by governance-conscious, enterprise-grade AI that preserves client ownership and specializes in regulated industries with Fortune 500 clients. The goal is to enable organizations to deploy reliable AI that drives real business results while maintaining control over data and intellectual property.

Company size
501-1,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Kirkland, WA
Founded
2020

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