[Hiring] Pharmaceutical CMC Regulatory Affairs Subject Matter Expert @Volga Partners

Role Description

Help Shape the Future of AI in Pharmaceutical. 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?

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.

• 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.

Qualifications

• 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

Requirements

• 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.

Benefits

• Compensation: $20-$50 USD/hour, based on specialty, experience, and project requirements
• Work Remotely: Participate in project-based assignments from an eligible location, with flexibility based on project availability.
• Explore the Future of Pharmaceutical Technology: Gain experience contributing to AI evaluation initiatives while leveraging your existing regulatory expertise.

Company Description

Join Volga Partners and help shape the next generation of pharmaceutical AI. Apply today to be considered for upcoming project opportunities.