Regulatory Affairs Documentation AI Training Specialist

About OpenTrain

OpenTrain is the #1 platform for finding and building careers in AI training and data labeling. It helps professionals discover specialized projects, build a credible AI training profile, and apply in minutes. Creating an OpenTrain account is free.

In this role, OpenTrain AI is hiring and contracting with an experienced regulatory affairs professional to help improve AI systems that work with complex regulatory documentation.

• Remote contractor opportunity
• Part-time engagement with a commitment of 20+ hours per week
• Worldwide opportunity for qualified professionals
• English-language work

About AI Training Work

AI training is the human side of building artificial intelligence. Experienced professionals review examples, assess model-generated content, and provide structured feedback so AI systems can produce more accurate, useful, and reliable results.

Your regulatory judgment will help evaluate whether AI-generated or drafted responses are substantiated, appropriately scoped, internally consistent, and defensible under regulatory scrutiny.

• Work directly with cutting-edge AI development
• Apply specialized professional knowledge to model evaluation
• Support clearer and more dependable AI-assisted regulatory workflows

The Role

As a Regulatory Affairs Documentation AI Training Specialist, you will evaluate and improve AI systems that work with agency-request scenarios, sponsor response threads, clinical records, safety documentation, and related document sets.

The role combines hands-on regulatory affairs expertise with careful assessment of substantive adequacy. You will distinguish responses that genuinely meet regulatory expectations from writing that appears polished but remains incomplete, unsupported, or difficult to defend.

• Role focus: regulatory affairs document review
• Data types: regulatory and clinical documents
• Core work types: evaluation, rating, and text generation
• Listing classification: entry level, with substantial professional experience required

What You'll Do

You will create and review realistic evaluation tasks based on regulatory affairs work, then explain your conclusions through structured, well-reasoned written feedback. Judgments should be grounded in applicable regulatory guidance rather than subjective impressions.

• Author and review evaluation tasks inspired by agency requests and sponsor response threads.
• Determine whether drafted responses meet regulatory expectations.
• Distinguish substantive adequacy from polished but insufficient writing.
• Review clinical and safety documentation for unsupported conclusions, conflicting claims, regulatory risks, and potential reviewer concerns.
• Assess consistency across comprehensive document sets.
• Explain deficiencies with concise, structured, and defensible written feedback.
• Communicate complex regulatory concepts clearly in written and verbal collaboration.

Required Qualifications

This role requires direct regulatory affairs experience involving clinical submissions and health authority interactions. You should be able to make concise, defensible regulatory judgments and communicate them clearly.

• At least five years of direct regulatory affairs experience with responsibility for clinical submissions at a sponsor, CRO, or consultancy.
• Experience drafting or leading responses to health authority information requests for ongoing regulatory filings.
• Working knowledge of the ICH framework and CTD/eCTD structure.
• Practical understanding of at least one major regulatory body's expectations.
• Ability to critically assess clinical or safety documents for unsupported claims, conflicting statements, and regulatory risks.
• Strong critical-reading and written communication skills.
• A degree in life sciences, pharmacy, medicine, or a related field.

Helpful Background

Additional regulatory breadth or experience with AI-assisted regulatory tools can strengthen your fit for this project. Relevant agency experience may come from work with one or more of the following organizations.

• Experience across multiple regions or regulatory agencies
• Prior health authority reviewer or assessor experience
• Regulatory Affairs Certification, or RAC
• Familiarity with AI-assisted regulatory tools
• Experience with the FDA, EMA, MHRA, PMDA, or Health Canada

Compensation and Engagement

This is a remote contractor opportunity for an individual professional contributing specialized regulatory expertise to AI training work. The role is part time and requires 20+ hours per week.

The advertised hourly range is $50-$70 per hour. Structured listing information also records an hourly maximum of $80, so confirm the applicable rate during the application process.

• Employment type: contractor
• Schedule: part time
• Time requirement: 20+ hours per week
• Advertised compensation: $50-$70 per hour
• Location: worldwide and remote

Why Build an AI Training Career

AI training and data labeling are among the fastest-growing ways to work in tech. Professionals prepare and review the examples that modern AI systems learn from, including written responses, documents, images, audio, and specialized expert content.

OpenTrain helps you build a lasting profile around this work, discover projects aligned with your expertise, and grow specialized AI training experience into a long-term portfolio.

• Contribute to how state-of-the-art AI systems behave
• Use your existing professional expertise in a growing field
• Work remotely with flexible project opportunities
• Build a portfolio of specialized AI training experience

How to Apply

Create a free OpenTrain account, complete your professional profile, and apply for this regulatory affairs documentation project. Highlight your clinical submission experience, health authority response work, regulatory frameworks, and document review strengths.

• Show your direct regulatory affairs experience.
• Emphasize clinical submissions and information request responses.
• Include relevant agency, regional, certification, or AI-tool experience.
• Apply through OpenTrain in minutes.