Regulatory Affairs Specialist

Apply regulatory affairs expertise to help train next-generation AI systems for regulatory documentation. This remote contract role focuses on evaluating realistic agency requests, sponsor responses, and clinical documentation using sound regulatory judgment. Prior AI experience is not required.

• Author and review evaluation tasks based on real-world agency requests and sponsor response threads, determining whether draft responses meet regulatory expectations.
• Review clinical documentation to assess whether conclusions are supported, commitments are appropriately scoped, and records can withstand regulatory scrutiny.
• Differentiate between substantively adequate and merely polished responses, and document clear reasons for deficiencies.
• Evaluate consistency across document sets and identify unsupported or conflicting claims within and between documents.
• Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines.
• Collaborate asynchronously and explain complex regulatory concepts clearly in writing and verbally.

• 5+ years of direct regulatory affairs experience at a sponsor, CRO, or consultancy, including responsibility for clinical submissions.
• Experience drafting or leading responses to health authority information requests, particularly for active regulatory filings.
• Working knowledge of the ICH framework, CTD/eCTD structure, and the practical expectations of at least one major regulatory body, including FDA, EMA, MHRA, PMDA, or Health Canada.
• Ability to critically assess clinical or safety documents for regulatory risks, unsupported statements, and potential reviewer concerns.
• Strong written communication, critical-thinking, attention-to-detail, regulatory-submission, health-authority-interaction, and remote-collaboration skills.
• A degree in life sciences, pharmacy, medicine, or a related field. RAC certification is an advantage.
• Experience working across multiple regions or agencies, prior health authority reviewer or assessor experience, or familiarity with AI-assisted regulatory tools is valuable.

• Remote contract engagement.

• $50 to $80 per hour.