Regulatory Affairs AI Training Specialist

The work

You will help evaluate and improve AI systems that work with regulatory documentation. Your work will use professional regulatory judgment to assess agency requests, sponsor response threads, clinical records, safety documentation, and related document sets.

You will create and review evaluation tasks, judge whether drafted responses meet regulatory expectations, and provide clear written and verbal feedback. The goal is to identify unsupported conclusions, conflicting claims, regulatory risks, and responses that sound polished but are not substantively adequate.

• Author and review evaluation tasks based on agency requests and sponsor response threads.
• Assess whether drafted responses are supported, appropriately scoped, internally consistent, and defensible under regulatory review.
• Review clinical and safety documentation for unsupported conclusions, conflicting claims, regulatory risks, and likely reviewer concerns.
• Check consistency across complete document sets and explain deficiencies with structured, well-reasoned feedback.
• Base judgments on applicable regulatory guidance rather than personal preference.
• Explain complex regulatory concepts clearly in writing and during collaboration.

What it pays and takes

This is a remote, part-time contractor role for an individual professional contributing specialized regulatory expertise to AI training work. The listing describes the role as entry level, but the stated requirements call for substantial direct regulatory affairs experience.

• Pay: The structured pay details list $50 to $80 per hour; the role description advertises $50 to $70 per hour.
• Time: 20 or more hours per week.
• Location: Remote, with eligibility limited to the countries listed for this role.
• Language: English.
• Experience: At least five years of direct regulatory affairs work involving clinical submissions at a sponsor, CRO, or consultancy.
• Submission experience: Experience drafting or leading responses to health authority information requests for ongoing regulatory filings.
• Knowledge: Working knowledge of the ICH framework, CTD/eCTD structure, and the practical expectations of at least one major regulatory body.
• Education: A degree in life sciences, pharmacy, medicine, or a related field.
• Core skills: Strong critical reading and written communication, including concise and defensible regulatory judgment.

Helpful background

Experience across multiple regions or agencies, prior health authority reviewer or assessor work, RAC certification, or familiarity with AI-assisted regulatory tools may be useful. Relevant agencies include the FDA, EMA, MHRA, PMDA, and Health Canada.

How it works

Apply on OpenTrain with your resume and then complete the application on the hiring site.

About AI training work

AI training work is the human review and preparation that helps AI systems produce better results. OpenTrain is the hiring and contracting organization for this role, giving contributors a place to find and build work in AI training and data labeling. Experienced professionals are paid for applying specialized knowledge to judge whether AI-generated work is accurate, useful, and safe.