23D AGO

Regulatory Affairs Specialist

micro1 / Regulatory Affairs Specialist

RATE

$50 - $70/HR

LOCATION

REMOTE (GLOBAL)

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DESCRIPTION

Role Title: Regulatory Affairs Specialist Role Type: Contractor Location: Remote micro1 is 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 • 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. • Distinguish 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 regulatory concepts clearly in both written and verbal form. Preferred

REQUIREMENTS

▸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 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/assessor background, or familiarity with AI-assisted regulatory tools (all considered valuable).