Regulatory CMC Submission Writer Subject Matter Expert -AI Model Evaluation

Volga Partners; United States; Remote; USD 28,000 - 69,000; Full time

Benefits offered by this job

Remote work

Project-based engagements

Freelance compensation

Job summary

Volga Partners seeks experienced Regulatory Affairs professionals to evaluate AI-generated regulatory content for accuracy and clarity. This role emphasizes technical review over filing submissions.

As a freelance, project-based SME, you will assess CTD/eCTD content, Module 3, and supporting documentation, providing expert feedback to improve AI model performance.

Remote work from the United States is possible; assignments are intermittent and compensation is hourly.

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.

Responsibilities

• Evaluate AI-generated pharmaceutical content: assess accuracy, completeness, consistency, and regulatory compliance
• Review regulatory documentation: CTD/eCTD, Module 3, manufacturing, analytical data, validation summaries, stability reports
• Analyze technical reasoning: ensure conclusions are supported by evidence and regulatory expectations
• Identify errors and inconsistencies: detect unsupported claims, technical inaccuracies, deficiencies
• Validate information: reference FDA requirements, ICH guidelines, CTD standards, best practices
• Provide expert feedback: explain findings and recommend corrections
• Support AI quality improvement: apply evaluation criteria and quality standards
• Complete independent evaluations: use online platforms and meet timelines

Skills

Regulatory writing

CMC documentation

Regulatory affairs

Pharmaceutical submissions

Technical writing

English proficiency

Independent work

Education

Bachelor’s degree or higher in Pharmacy/Pharmaceutical Sciences

Job description

Remote | United States | Project-Based Independent Contractor

Compensation: $20-$50 USD/hour, based on specialty, experience, and project requirements

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, and 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.

The Opportunity

As a Regulatory CMC Submission Writer Subject Matter Expert (SME), you'll serve as a subject matter evaluator, helping assess the quality, accuracy, completeness, and regulatory compliance of Pharmaceutical AI-generated content.

You'll analyze regulatory, scientific, manufacturing, analytical, and technical documentation scenarios, identify errors or unsupported conclusions, and provide expert feedback grounded in established submission standards, regulatory requirements, and industry best practices.

Your contributions will help improve how AI systems understand and respond to complex pharmaceutical regulatory documentation and submission challenges.

What You'll Do

• Evaluate AI-generated pharmaceutical content: Assess scientific, technical, and regulatory responses for accuracy, completeness, consistency, and compliance with submission requirements.
• Review regulatory documentation: Examine content related to CTD/eCTD submissions, Module 3 documentation, manufacturing information, analytical data, validation summaries, and stability reports.
• Analyze technical reasoning: Determine whether AI-generated conclusions are supported by scientific evidence, regulatory expectations, and accepted documentation practices.
• Identify errors and inconsistencies: Recognize unsupported claims, technical inaccuracies, documentation deficiencies, missing context, and flawed regulatory reasoning.
• Validate information: Reference FDA requirements, ICH guidelines, CTD standards, and accepted pharmaceutical industry practices.nt FDA requirements, GMP regulations, ICH guidelines, and accepted pharmaceutical industry practices.
• Provide expert feedback: Clearly explain findings, identify opportunities for improvement, and recommend technically accurate corrections.
• Support AI quality improvement: Apply project-specific evaluation criteria, scoring guidelines, and quality standards.
• Complete independent evaluations: Use designated online platforms to complete assignments accurately and within established project timelines.

Why Join Volga Partners?

Apply Your Industry Expertise in a New Way
Use the knowledge you've developed throughout your pharmaceutical or biotechnology career to contribute to advanced AI technologies.

Help Improve Scientific Accuracy
Your evaluations will help strengthen the quality and reliability of AI-generated pharmaceutical and regulatory information.

Work Remotely
Participate in project-based assignments from an eligible location, with flexibility based on project needs and availability.

Explore the Future of Pharmaceutical Technology
Gain experience contributing to AI evaluation initiatives while applying your existing scientific and regulatory expertise.

No AI Background Required
We're looking for professionals who can recognize accurate scientific reasoning, identify errors, and communicate expert assessments with clarity.

Compensation:

Volga Partners offers project-based hourly compensation based on specialization, relevant experience, professional qualifications, geographic location, and assignment requirements.

Regulatory CMC Submission Writer Subject Matter Expert (SME): $25-$50 USD/hour

Compensation may vary based on experience level, area of expertise, and task complexity.

Project Details

• Engagement Type: Project-based independent contractor
• Work Arrangement: Remote
• Primary Location: United States preferred
• Additional Markets: Professionals outside the United States may be considered if they possess substantial U.S. pharmaceutical industry experience
• Schedule: Variable and assignment-based
• Project Type: Pharmaceutical AI content evaluation
• Project Duration: Based on project requirements and assignment availability
• Selection Process: Qualified candidates may be required to complete screening questions and evaluation exercises prior to project selection

Specific assignments, schedules, workloads, and project dates will be communicated as they are confirmed. Hours and future assignments are not guaranteed.

Bring Your Pharmaceutical Expertise to the Future of AI

If you're an experienced pharmaceutical or biotechnology professional who enjoys analyzing complex scientific information, applying regulatory and technical expertise, and contributing to innovative technology, we'd love to hear from you.

Join Volga Partners and help shape the next generation of pharmaceutical AI.

Who We're Looking For

We're seeking experienced Regulatory Affairs professionals in the Pharmaceutical world who bring practical industry expertise and are comfortable reviewing technical information, exercising independent judgment, and clearly explaining their conclusions.

Required 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 documentationFamiliarity 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.

Preferred Qualifications

We encourage applications from professionals with backgrounds such as:

• 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 is beneficial but not required.