[Hiring] Regulatory CMC Submission Writer Subject Matter Expert @Volga Partners

Role Description

Help Shape the Future of AI in Pharmaceutical. What if your expertise in regulatory writing, CMC documentation, and global pharmaceutical submissions could help artificial intelligence better understand regulatory requirements, technical documentation standards, and submission best practices?

At Volga Partners, we're connecting experienced pharmaceutical professionals with opportunities to contribute to the development and evaluation of advanced AI models. We're seeking experienced Regulatory CMC Submission Writers who can apply their regulatory writing expertise, scientific knowledge, and technical documentation experience to evaluate AI-generated pharmaceutical and regulatory content.

This isn't a traditional regulatory writing position. You won't be authoring submissions for health authorities, coordinating submission timelines, or supporting active filing activities. Instead, you'll:

• Evaluate complex regulatory and scientific content.
• Identify technical inaccuracies.
• Assess document quality and regulatory reasoning.
• Provide structured feedback that improves AI model performance.

Your pharmaceutical expertise is what matters. AI experience is a plus, not a requirement.

Important Note: This is a freelance, task-based role designed for those seeking supplemental income. It’s essential to understand the nature of freelance work—tasks will be assigned as they become available, and work may be irregular or intermittent.

Qualifications

• Minimum of 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.

Requirements

• 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 is beneficial but not required.

Benefits

• Apply your industry expertise in a new way.
• Help improve scientific accuracy.
• Work remotely with flexibility based on project needs and availability.
• Explore the future of pharmaceutical technology.
• No AI background required.

Company Description

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