About this opportunity
Confidential lists this Regulatory Affairs Specialist opportunity in Windsor Hills, California. Review the employer’s description below for duties, qualifications and application requirements.
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.
Qualifications 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.
Work Terms Remote contract engagement.
Compensation $50 to $80 per hour.
Application Process Apply by providing your email address. Continuing the application confirms acknowledgment of the applicable candidate terms and privacy policy.
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.