Regulatory Affairs Documentation AI Training Specialist

About OpenTrain

OpenTrain AI is the hiring and contracting organization for this role and the #1 platform for finding and building careers in AI training and data labeling. OpenTrain helps professionals discover specialized projects, build a credible AI training profile, and grow their experience in this rapidly expanding field.

About AI Training Work

AI training is the human side of building modern artificial intelligence. Expert contributors review documents, evaluate model-generated responses, and provide structured feedback so AI systems can become more accurate, useful, and reliable. This work is remote and can offer flexible opportunities to apply professional expertise to cutting-edge technology.

The Role

OpenTrain AI is seeking a Regulatory Affairs Documentation AI Training Specialist to evaluate and improve AI systems that work with regulatory documentation. You will apply professional regulatory judgment to agency-request scenarios, sponsor response threads, clinical records, and related document sets.

This role combines hands-on regulatory affairs experience with careful assessment of whether AI-generated or drafted responses are substantiated, appropriately scoped, internally consistent, and defensible under regulatory scrutiny.

• Remote contractor opportunity for an individual professional
• Part-time engagement requiring 20+ hours per week
• Advertised compensation of $50–$70 per hour
• Primary language: English

What You'll Do

You will create and assess realistic evaluation tasks, review clinical and safety documentation, and explain your conclusions in clear, structured feedback. Your work will help distinguish responses that are genuinely adequate from writing that appears polished but does not meet regulatory expectations.

• Author and review evaluation tasks inspired by agency requests and sponsor response threads.
• Determine whether drafted responses meet applicable regulatory expectations.
• Identify unsupported conclusions, conflicting claims, regulatory risks, and likely reviewer concerns.
• Assess consistency across comprehensive document sets.
• Explain deficiencies with structured, well-reasoned written feedback.
• Ground judgments in applicable regulatory guidance rather than subjective impressions.
• Communicate complex regulatory concepts clearly in written and verbal collaboration.

Required Qualifications

This opportunity is labeled entry level in the source role data, but the work itself requires substantial professional experience. Applicants must meet the specific regulatory affairs requirements below.

• At least five years of direct regulatory affairs experience involving 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 agency's expectations.
• Strong critical-reading and written communication skills.
• Ability to make concise, clear, and defensible regulatory judgments.
• Degree in life sciences, pharmacy, medicine, or a related field.

Helpful Background

The following experience is valuable but is listed as helpful rather than required. Relevant regulatory environments include the FDA, EMA, MHRA, PMDA, and Health Canada.

• Experience working across multiple regions or regulatory agencies
• Previous health authority reviewer or assessor experience
• RAC certification
• Familiarity with AI-assisted regulatory tools

Why Join OpenTrain

OpenTrain AI gives professionals a way to build lasting experience in AI training and data labeling while applying the expertise they already have. By contributing to projects that shape how AI systems understand and evaluate specialized information, you can develop a portfolio that reflects your capabilities and discover future opportunities aligned with your skills.

• Work remotely with flexible part-time scheduling.
• Apply specialized regulatory expertise to emerging AI systems.
• Build experience in a fast-growing area of technology.
• Create an OpenTrain profile to showcase your AI training work.