Regulatory Affairs Specialist

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

1. Author and review evaluation tasks inspired by real-world agency requests and sponsor response threads, determining if drafted responses meet regulatory expectations.
2. Apply expert judgment to review clinical documentation, assessing whether conclusions are substantiated, commitments are properly scoped, and records can withstand regulatory scrutiny.
3. Distinguish between substantively adequate and superficially polished responses, articulating clear rationales for any deficiencies.
4. Assess consistency across comprehensive document sets, identifying unsupported or conflicting claims within or between documents.
5. Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines rather than subjective impressions.
6. Collaborate asynchronously and communicate complex regulatory concepts clearly in both written and verbal form.

Preferred Qualifications

1. 5+ years of direct regulatory affairs experience at a sponsor, CRO, or consultancy, with responsibility for clinical submissions.
2. Documented experience drafting or leading responses to health authority information requests, particularly for ongoing regulatory filings.
3. 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).
4. Proven ability to critically read clinical or safety documents to identify regulatory risks, unsupported statements, and potential reviewer concerns.
5. Exceptional written communication skills, with the capability to convey regulatory reasoning clearly, concisely, and defensibly.
6. Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.
7. Experience engaging with multiple regions or agencies, prior health authority reviewer/assessor background, or familiarity with AI-assisted regulatory tools (all considered valuable).