YO HR Consultancy

Role Title: Regulatory Affairs Specialist
Role Type: Contractor
Location: Remote
Engaging Regulatory Affairs Specialists to contribute to a customer's 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
<ul>
<li>Author and review evaluation tasks inspired by real-world agency requests and sponsor response threads, determining if drafted responses meet regulatory expectations.</li>
<li>Apply expert judgment to review clinical documentation, assessing whether conclusions are substantiated, commitments are properly scoped, and records can withstand regulatory scrutiny.</li>
<li>Distinguish between substantively adequate and superficially polished responses, articulating clear rationales for any deficiencies.</li>
<li>Assess consistency across comprehensive document sets, identifying unsupported or conflicting claims within or between documents.</li>
<li>Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines rather than subjective impressions.</li>
<li>Collaborate asynchronously and communicate complex regulatory concepts clearly in both written and verbal form.</li>
</ul>
Preferred Qualifications
<ul>
<li>5+ years of direct regulatory affairs experience at a sponsor, CRO, or consultancy, with responsibility for clinical submissions.</li>
<li>Documented experience drafting or leading responses to health authority information requests, particularly for ongoing regulatory filings.</li>
<li>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).</li>
<li>Proven ability to critically read clinical or safety documents to identify regulatory risks, unsupported statements, and potential reviewer concerns.</li>
<li>Exceptional written communication skills, with the capability to convey regulatory reasoning clearly, concisely, and defensibly.</li>
<li>Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.</li>
<li>Experience engaging with multiple regions or agencies, prior health authority reviewer/assessor background, or familiarity with AI-assisted regulatory tools (all considered valuable).</li>
</ul>