Experience: 5+ years
Job Type: Full-time (Contractual / Freelancing)
Location: Remote (Candidates from US only)
Required Skills: regulatory affairs, clinical documentation review, ich guidelines, ctd/ectd structure, written communication, critical thinking, regulatory submissions, health authority interactions, attention to detail, remote collaboration
Job Summary:
We are engaging Regulatory Affairs Specialists to contribute to a project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required, your domain knowledge is what matters.
Scope of Work:
- Author and review evaluation tasks inspired by real-world agency requests and sponsor response threads, determining if drafted responses meet regulatory expectations.
- Apply expert judgment to review clinical documentation, assessing whether conclusions are substantiated, commitments are properly scoped, and records can withstand regulatory scrutiny.
- Distinguishing between substantively adequate and superficially polished responses, articulating 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 organizational concepts clearly in both written and verbal form.
Preferred Qualifications:
- 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.
- Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (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, with the ability 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/assessor background, or familiarity with AI-assisted regulatory tools (all considered valuable).