Job Description

Apply regulatory affairs expertise to help train next-generation AI systems for regulatory documentation. This remote contract role focuses on evaluating real-world regulatory scenarios and providing rigorous, evidence-based feedback. Prior AI experience is not required. Key Responsibilities

• Author and review evaluation tasks based on agency requests and sponsor response threads, assessing whether drafted responses meet regulatory expectations.
• Review clinical documentation to determine whether conclusions are supported, commitments are appropriately scoped, and records can withstand regulatory scrutiny.
• Differentiate substantively adequate responses from polished but deficient ones, with clear explanations of identified gaps.
• Evaluate consistency across document sets and identify unsupported or conflicting claims within and between documents.
• Provide structured written feedback grounded in applicable regulatory guidelines.
• Collaborate asynchronously and communicate complex regulatory concepts clearly in writing and verbally.

• 5+ years of direct regulatory affairs experience with 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 ICH guidelines, CTD/eCTD structure, and the practical expectations of at least one major regulatory authority, 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.
• Exceptional written communication, critical-thinking, attention-to-detail, and remote-collaboration skills.
• Degree in life sciences, pharmacy, medicine, or a related discipline; RAC certification is a plus.
• Experience working across multiple regions or agencies, prior health authority reviewer or assessor experience, and familiarity with AI-assisted regulatory tools are valuable.

• Remote contract engagement.

• $50 to $80 per hour.

• Apply by providing your email address. Continuing the application confirms acknowledgment of the applicable candidate terms and privacy policy.

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