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Posted 4 Aug 2026

Regulatory Affairs Specialist

micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation.

Remote$50–$80 per hour
Hiring companyMicro1
Application processN/A1 of 3 reviews needed
Work experienceN/A1 of 3 reviews needed

About the role

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.

Responsibilities

  • 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 skills

  • 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).

Eligibility

Work arrangement: Fully remote

Compensation details

$50–$80 per hour.

More about the hiring companyMicro1
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