[Hiring] Pharmaceutical Subject Matter Expert @Volga Partners

Role Description

Help Shape the Future of AI in Healthcare. What if your pharmaceutical expertise could help artificial intelligence better understand regulatory requirements, scientific documentation, manufacturing processes, and quality standards?

As a Pharmaceutical Subject Matter Expert (SME), you'll serve as a subject matter evaluator, helping assess the quality, accuracy, and reasoning of AI-generated pharmaceutical and biotechnology content.

• 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 technical reasoning to determine whether AI-generated conclusions are supported by relevant scientific principles, regulatory expectations, and industry best practices.
• Identify errors and inconsistencies, recognizing unsupported claims, technical inaccuracies, missing context, and flawed reasoning.
• Validate information by referencing relevant FDA requirements, GMP regulations, ICH guidelines, and accepted pharmaceutical industry practices.
• Provide expert feedback by clearly explaining findings, identifying opportunities for improvement, and recommending technically accurate corrections.
• Support AI quality improvement by applying project-specific evaluation criteria, scoring guidelines, and quality standards.
• Complete independent evaluations using designated online platforms to complete assignments accurately and within established project timelines.

Qualifications

• Minimum of four years of relevant professional experience in the regulated pharmaceutical or biotechnology industry.
• Bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Engineering, Regulatory Affairs, or a related discipline.
• Strong expertise in at least one pharmaceutical specialty listed in the areas of expertise.
• Working knowledge of FDA requirements, GMP regulations, and relevant ICH guidelines, including applicable portions of ICH Q7-Q12.
• Ability to critically evaluate scientific, technical, and regulatory information.
• Strong analytical, research, and problem-solving abilities.
• Excellent written English communication skills.
• Confidence reviewing complex information and explaining technical conclusions.
• Comfort using digital platforms, web-based applications, and online research tools.
• Ability to work independently, follow detailed instructions, and meet established quality standards.
• Must understand and be comfortable with a task-based freelance engagement model.

Requirements

• Experience preparing or reviewing regulatory submissions (IND, NDA, BLA, ANDA, MAA, or equivalent).
• Experience with FDA-regulated manufacturing, quality, compliance, validation, or development environments.
• Experience performing quality reviews, regulatory audits, or scientific content evaluations.
• Experience with technical writing, structured reviews, or compliance assessments.
• Familiarity with AI model evaluation, prompt review, rubric development, or data annotation.
• Previous involvement in scientific, regulatory, quality, or technical content assessment activities.
• Experience with AI model evaluation, large language models (LLMs), research, or structured quality assessments is beneficial but not required.

Benefits

• Apply your industry expertise in a new way, contributing to advanced AI technologies.
• Help improve scientific accuracy, strengthening the quality and reliability of AI-generated pharmaceutical and regulatory information.
• Work remotely with flexibility based on project needs and availability.
• Gain experience contributing to AI evaluation initiatives while applying your existing scientific and regulatory expertise.
• No AI background required; we seek professionals who can recognize accurate scientific reasoning and communicate expert assessments with clarity.