Pharmaceutical CMC Regulatory Affairs Subject Matter Expert -AI Model Evaluation
About The Position
Volga Partners is seeking experienced Pharmaceutical Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs professionals to evaluate AI-generated pharmaceutical and regulatory content. The role involves assessing content for scientific and technical accuracy, completeness, consistency, regulatory compliance, and sound reasoning. Evaluators identify unsupported claims, technical inaccuracies, missing context, and flawed conclusions, and provide clear, structured feedback and technically accurate corrections grounded in industry standards and regulatory frameworks. This is not a traditional regulatory affairs role: the work does not involve preparing submissions, managing product registrations, or interacting with health authorities. Assignments are completed independently through designated online platforms using project-specific evaluation criteria, scoring guidelines, and quality standards. Work is remote, project-based, and task-driven; tasks are assigned as available, so schedules and workloads may be irregular or intermittent, and future hours and assignments are not guaranteed. Candidates may need to complete screening questions and evaluation exercises before selection.
Requirements
- At least 4 years of professional experience in CMC Regulatory Affairs.
- 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 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.
- Comfort with a task-based freelance engagement model.
Nice To Haves
- 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.
Responsibilities
- Evaluate AI-generated pharmaceutical content for scientific, technical, and regulatory accuracy, completeness, consistency, and compliance with industry standards.
- Review scientific and regulatory information relating to quality systems, manufacturing, validation, submissions, development, and compliance activities.
- Assess whether AI-generated conclusions are supported by scientific principles, regulatory expectations, and industry best practices.
- Identify unsupported claims, technical inaccuracies, missing context, inconsistencies, and flawed reasoning.
- Validate information against relevant FDA requirements, GMP regulations, ICH guidelines, and accepted pharmaceutical industry practices.
- Provide clear expert feedback, explain findings, and recommend technically accurate corrections.
- Apply project-specific evaluation criteria, scoring guidelines, and quality standards to support AI quality improvement.
- Complete independent evaluations on designated online platforms accurately and within established project timelines.
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What This Job Offers
Career Level
Mid Level
