Regulatory CMC Submission Writer Subject Matter Expert -AI Model Evaluation
The middle of its range, $35/hr, is below the $60/hr median of the Writing & Content roles open now, whose typical pay runs $40–$140/hr. How that pay moves week by week is in our research on Writing & Content work.
Half of all Writing & Content roles come down within 9.2 days of being listed, and 34.6% are still up after four weeks. This one was posted today.
About the role
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.
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.
Apply today to be considered for upcoming project opportunities.
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 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.
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.
Where you can work
This role is 100% remote, for applicants located in United States.
From Volga Partners's job posting, checked 30 Oct 2026.
The application
Your details, CV and LinkedIn, then 26 questions (2 written).
- 1.HeadlineShort answer · optional
- 2.EducationShort answer · optional
- 3.ExperienceShort answer · optional
- 4.SummaryWritten answer · optional
- 5.Are you currently based in the United States?Yes or no
- 6.Are you authorized to work in the United States?Yes or no
- 7.If yes, which state are you currently residing?Short answer
- 8.How many years of professional experience do you have in the regulated pharmaceutical or biotechnology industry?Pick any: 6584083 · 6584084 · 6584085 · 6584086
- 9.Which pharmaceutical specialties match your professional experience?Pick any (9 options)
- 10.Which settings account for your relevant professional experience?Pick any (9 options)
- 11.What is your highest completed qualification relevant to this role?Pick any: 6584105 · 6584106 · 6584107 · 6584108 · 6584109 · 6584110
- 12.Employment supporting U.S. pharmaceutical / biotechnology operationsPick any: 6584111 · 6584112 · 6584113 · 6584114 · 6584115 · 6584116
- 13.Have you previously evaluated AI-generated medical content, participated in medical AI training, or performed structured clinical quality reviews?Pick any: 6584117 · 6584118 · 6584119 · 6584120
- 14.Which standards have you applied in your professional work?Pick any (8 options)
- 15.Where will you be physically located while performing this project?Pick any: 6584129 · 6584130
- 16.If outside Unites States, provide which country.Short answer
- 17.Can you complete selection and onboarding steps and be available for potential participation beginning Monday, October 26, 2026?Pick one: 6584131 · 6584132 · 6584133 · 6584134
- 18.Which days can you regularly accept on-call assignments?Pick any (7 options)
- 19.How many hours per week could you make available if assignments are offered?Pick any: 6584142 · 6584143 · 6584144 · 6584145 · 6584146
- 20.What hourly rate in USD would you accept for this content evaluation scope?Pick any: 6584147 · 6584148 · 6584149 · 6584150 · 6584151
- 21.Which relevant review activities have you performed? Select All That ApplyPick any (7 options)
- 22.List your ongoing working windows and time zone. Include any scheduling restrictions.Written answer
- 23.Are you comfortable evaluating AI-generated medical responses, identifying inaccuracies, and providing structured written feedback in English?Yes or no
- 24.Must understand and accept that this is a task-based, freelance role. [Task-Based Project Scope] This is a freelance, task-based role designed for those seeking supplemental income. It’s essential to understand the nature of freelance work-Yes or no
- 25.Do you understand this is an on-call freelance project, with assignments subject to confirmation and task availability rather than guaranteed weekly hours?Yes or no
- 26.Are you willing to work remotely as a project-based independent contractor, with hours and assignments varying according to project requirements?Yes or no
From Volga Partners's apply page, checked 30 Oct 2026.
About Volga Partners
An AI data company that hires on-call subject-matter experts and language reviewers for AI evaluation projects; US expert roles pay $35 to $60 an hour, healthcare students and trainees $15 to $35 (its postings, 27 Oct 2026).
How it pays: Not stated beyond the hourly rate; US expert roles are 1099 independent contracts, and a shortlisted candidate completes a trial task that is paid only if it meets the standard.
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