Regulatory Affairs Specialist

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 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 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).