Regulatory Affairs Specialist

Apply regulatory affairs expertise to help improve AI systems used for regulatory documentation. This remote contractor role focuses on evaluating real-world regulatory scenarios, clinical documentation, and sponsor responses against applicable regulatory expectations.

• Create and review evaluation tasks based on agency information requests and sponsor response threads, determining whether proposed responses meet regulatory expectations.
• Review clinical documentation to assess whether conclusions are supported, commitments are appropriately scoped, and records can withstand regulatory scrutiny.
• Identify the difference between substantively adequate responses and polished but insufficient responses, and clearly explain deficiencies.
• Evaluate consistency across document sets and flag unsupported or conflicting claims within and between documents.
• Provide structured, well-reasoned written feedback grounded in relevant regulatory guidelines.
• Collaborate asynchronously and communicate 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, such as the FDA, EMA, MHRA, PMDA, or Health Canada.
• Ability to critically review clinical or safety documents for regulatory risks, unsupported statements, and potential reviewer concerns.
• Exceptional written communication, critical-thinking, and attention-to-detail skills.
• 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, and familiarity with AI-assisted regulatory tools are valuable.

• Remote independent contractor engagement.
• No prior AI experience is required. Regulatory domain expertise is the primary requirement.

$50 to $70 per hour.