Regulatory Affairs Specialist for AI Training [Remote]

Apply your regulatory affairs expertise to evaluate and shape regulatory documentation that will train next-generation AI systems. In this contractor, fully remote role you will review clinical and regulatory submissions content, judge whether drafted responses meet health authority expectations, and provide structured, guideline-driven feedback that improves how AI models learn regulatory reasoning. No prior AI experience is required; domain knowledge and regulatory judgment are the priority.

• Author and review evaluation tasks based on real-world agency requests and sponsor response threads to determine if drafted responses meet regulatory expectations.
• Review clinical documentation to assess whether conclusions are supported, commitments are appropriately scoped, and records can withstand regulatory scrutiny.
• Distinguish between substantively adequate responses and those that are only superficially polished, and document clear rationales for deficiencies.
• Assess consistency across comprehensive document sets, identifying unsupported or conflicting claims within or between documents.
• Provide structured, well-reasoned written feedback that cites applicable regulatory guidelines rather than subjective impressions.
• Collaborate asynchronously with project team members and communicate complex regulatory concepts clearly in written and verbal form.

• Required skills: regulatory affairs, clinical documentation review, familiarity with ICH guidelines, CTD/eCTD structure, strong written communication, critical thinking, experience with regulatory submissions, health authority interactions, attention to detail, and ability to work remotely.
• Preferred experience: 5+ years of direct regulatory affairs work 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 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, able to convey regulatory reasoning clearly, concisely, and defensibly.
• Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.
• Additional valued background includes experience engaging multiple regions or agencies, prior health authority reviewer or assessor experience, or familiarity with AI-assisted regulatory tools.

• Engagement type: independent contractor.
• Location: fully remote.
• Collaboration model: asynchronous communication and remote teamwork.

• Hourly rate: $50.00 to $70.00 per hour.

• Candidates must be able to contract as independent contractors and perform remote work from their location. Specific work authorization or sponsorship constraints are not provided; ensure you are legally eligible to engage as a contractor for a remote project.

If you are interested, prepare a resume or CV highlighting relevant regulatory submissions experience, examples of clinical documentation review or responses to health authority requests, and your availability. Submit these materials through the employer''s application channel or contact provided in the original posting. Shortlisted candidates will be asked to demonstrate relevant examples of regulatory reasoning and documentation review.