Regulatory CMC Submission Writer Subject Matter Expert -AI Model Evaluation

Volga Partners

8d • $25 - $50 • Remote

About The Position

Volga Partners is seeking experienced Regulatory CMC Submission Writers to evaluate AI-generated pharmaceutical and regulatory content. This is not a traditional regulatory writing role: the contractor will not author health authority submissions, coordinate submission timelines, or support active filings. Instead, the role involves assessing the accuracy, completeness, consistency, quality, and regulatory compliance of AI-generated content, then providing structured expert feedback to improve AI model performance.

Evaluations may cover regulatory, scientific, manufacturing, analytical, and technical documentation, including CTD/eCTD submissions, Module 3 CMC documentation, manufacturing information, analytical data, validation summaries, and stability reports. The evaluator will determine whether conclusions are supported by scientific evidence and regulatory expectations, identify technical inaccuracies and documentation deficiencies, and validate content against FDA requirements, GMP regulations, ICH guidelines, CTD standards, and accepted pharmaceutical industry practices.

This is a remote, project-based independent contractor engagement for supplemental income. Assignments are task-based and variable; work may be irregular or intermittent, and hours and future assignments are not guaranteed. Assignments are completed independently using designated online platforms and must follow project-specific evaluation criteria, scoring guidelines, quality standards, and timelines. Specific schedules, workloads, and project dates will be communicated as confirmed. Qualified candidates may need to complete screening questions and evaluation exercises before selection. The primary location is the United States, though professionals elsewhere may be considered if they have substantial U.S. pharmaceutical industry experience. Compensation is hourly and project-dependent; the posting lists $20–$50 USD/hour generally and $25–$50 USD/hour for this SME role, with rates varying based on experience, specialty, qualifications, location, and assignment requirements.

Requirements

• At least 4 years of professional experience in Regulatory Writing, CMC Documentation, Regulatory Affairs, or Pharmaceutical Submission Support.
• Bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Regulatory Affairs, Life Sciences, Engineering, or a related discipline.
• Experience authoring, reviewing, or supporting pharmaceutical regulatory submissions.
• Experience preparing CTD and/or eCTD documentation.
• Familiarity with Module 3 (CMC) documentation requirements.
• Knowledge of FDA regulations, CTD structure, and relevant ICH guidelines.
• Experience reviewing scientific, manufacturing, analytical, and stability documentation.
• Ability to critically evaluate scientific and regulatory information.
• Strong technical writing, editing, and document review skills.
• Strong analytical, research, and problem-solving abilities.
• Excellent written English communication skills.
• Ability to work independently and follow detailed review instructions.
• Must understand and be comfortable with a task-based freelance engagement model.

Nice To Haves

• RAC certification.
• PharmD, MS, MBA, PhD, or other advanced scientific credentials.
• Experience supporting IND, NDA, BLA, ANDA, MAA, or equivalent submissions.
• Experience preparing or reviewing Module 2 and Module 3 documentation.
• Knowledge of electronic submissions and eCTD publishing processes.
• Experience compiling manufacturing, analytical, validation, and stability data.
• Global regulatory submission experience.
• Experience performing submission readiness assessments and document quality reviews.
• Experience collaborating with Regulatory Affairs, Quality, Manufacturing, Analytical Development, and Technical Operations teams.
• 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 and technical accuracy, completeness, consistency, and compliance with submission requirements.
• Review regulatory documentation related to CTD/eCTD submissions, Module 3 documentation, manufacturing information, analytical data, validation summaries, and stability reports.
• Assess whether AI-generated technical reasoning and conclusions are supported by scientific evidence, regulatory expectations, and accepted documentation practices.
• Identify unsupported claims, technical inaccuracies, documentation deficiencies, missing context, and flawed regulatory reasoning.
• Validate information against FDA requirements, GMP regulations, ICH guidelines, CTD standards, and accepted pharmaceutical industry practices.
• Provide clear expert feedback, explain findings, identify improvement opportunities, and recommend technically accurate corrections.
• Apply project-specific evaluation criteria, scoring guidelines, and quality standards to support AI quality improvement.
• Complete independent evaluations accurately and within established project timelines using designated online platforms.

What This Job Offers

• Career Level: Mid Level