Regulatory Affairs Specialist for AI Training [Remote]

Apply your regulatory affairs expertise to author and review regulatory documentation evaluation tasks that will train next-generation AI systems. In this remote contractor role, you will evaluate whether drafted responses meet regulatory expectations, identify regulatory risks in clinical documents, and provide clear, guideline-based feedback that shapes how models learn regulatory reasoning. No prior AI experience is required, domain knowledge is the priority.

• Author and review evaluation tasks modeled on real-world agency requests and sponsor response threads, determining if drafted responses meet regulatory expectations.
• Review clinical documentation to assess whether conclusions are substantiated, commitments are properly scoped, and records can withstand regulatory scrutiny.
• Differentiate between substantively adequate and superficially polished responses, and articulate clear rationales for any deficiencies.
• Assess consistency across comprehensive document sets, identifying unsupported or conflicting claims within or between documents.
• Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines rather than subjective impressions.
• Collaborate asynchronously and communicate complex regulatory concepts clearly in both written and verbal form.

• 5+ years of direct regulatory affairs experience at a sponsor, CRO, or consultancy, with responsibility for clinical submissions.
• Documented experience drafting or leading responses to health authority information requests, particularly for ongoing regulatory filings.
• Working knowledge of the ICH framework, CTD/eCTD structure, and the practical expectations of at least one major regulatory body such as FDA, EMA, MHRA, PMDA, or Health Canada.
• Proven ability to critically read clinical or safety documents to identify regulatory risks, unsupported statements, and potential reviewer concerns.
• Exceptional written communication skills, critical thinking, and strong attention to detail, with the capability to convey regulatory reasoning clearly, concisely, and defensibly.
• Degree in life sciences, pharmacy, medicine, or a related field. RAC certification is an advantage.
• Experience engaging with multiple regions or agencies, prior health authority reviewer or assessor background, or familiarity with AI-assisted regulatory tools are valuable but not required.
• No prior experience in AI is required.

• Engagement type, independent contractor.
• Location, remote.
• Work is performed asynchronously and will require written and verbal communication to external-facing standards.

Hourly rate, $50.00 to $70.00 per hour.

• Scope of work includes authoring and reviewing evaluation tasks inspired by real-world agency requests and sponsor response threads, determining if drafted responses meet regulatory expectations.
• Contractor must be able to perform the described scope of work remotely and collaborate asynchronously.

If you are interested, follow the application instructions on this posting and provide a resume along with a brief summary of your regulatory submissions experience and relevant examples of work that demonstrate your ability to draft or review health authority responses.