Regulatory CMC Submission Writer – AI Model Evaluation

This is a fully remote position, open to applicants in United States.

📋 Description

• Assess AI-generated pharmaceutical content for scientific, technical, and regulatory accuracy, completeness, consistency, and compliance.

• Review CTD/eCTD submissions, Module 3 documentation, manufacturing information, analytical data, validation summaries, and stability reports.

• Evaluate whether AI-generated conclusions are backed by scientific evidence, regulatory expectations, and accepted documentation practices.

• Detect unsupported claims, technical inaccuracies, documentation shortcomings, missing context, and flawed regulatory reasoning.

• Reference FDA requirements, GMP regulations, ICH guidelines, CTD standards, and established pharmaceutical industry practices.

• Provide expert feedback, clarify findings, and suggest technically accurate corrections.

• Apply project-specific evaluation criteria, scoring guidelines, and quality standards.

• Conduct independent evaluations using designated online platforms within project timelines.

⛳️ 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 field.

• Experience in authoring, reviewing, or supporting pharmaceutical regulatory submissions.

• Experience in preparing CTD and/or eCTD documentation.

• Familiarity with Module 3 (CMC) documentation requirements.

• Knowledge of FDA regulations, CTD structure, and relevant ICH guidelines.

• Experience in reviewing scientific, manufacturing, analytical, and stability documentation.

• Ability to critically assess scientific and regulatory information.

• Strong technical writing, editing, and document review capabilities.

• Exceptional analytical, research, and problem-solving skills.

• Excellent written English communication skills.

• Ability to work independently and adhere to detailed review instructions.

• Must be comfortable with a task-based freelance engagement model.

• RAC certification.

• PharmD, MS, MBA, PhD, or other advanced scientific qualifications.

• Experience supporting IND, NDA, BLA, ANDA, MAA, or equivalent submissions.

• Experience in 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 conducting 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.

🏝️ Benefits

• Remote work.

• Flexible, variable, assignment-based schedule.

• Project-based freelance work for supplemental income.

• Opportunity to contribute to advanced AI technologies.

• Experience in contributing to AI evaluation initiatives.

• No AI background required.