Regulatory Affairs Specialist
$50 - $70 per hourSaidGig
Role Overview
Apply regulatory affairs expertise to help train next-generation AI systems for regulatory documentation. You will contribute high-quality, real-world evaluations and feedback that shape how models reason about clinical submissions, agency requests, and regulatory expectations. No previous AI experience is required.
Key Responsibilities
- Author and review evaluation tasks based on real-world health authority requests and sponsor response threads, determining whether drafted responses meet regulatory expectations.
- Review clinical documentation to assess whether conclusions are supported, commitments are appropriately scoped, and records can withstand regulatory scrutiny.
- Differentiate substantively adequate responses from those that are merely polished, and clearly explain deficiencies.
- Review complete document sets for unsupported, inconsistent, or conflicting claims within and across documents.
- Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines.
- Collaborate asynchronously and explain complex regulatory concepts clearly in writing and conversation.
Qualifications
- At least 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 body, including the FDA, EMA, MHRA, PMDA, or Health Canada.
- Ability to critically assess clinical or safety documents for regulatory risk, unsupported statements, and potential reviewer concerns.
- Exceptional written communication, critical-thinking, and attention-to-detail skills.
- A degree in life sciences, pharmacy, medicine, or a related discipline. RAC certification is advantageous.
- Experience across multiple regions or agencies, prior health authority reviewer or assessor experience, and familiarity with AI-assisted regulatory tools are valuable.
Work Terms
- Remote independent contractor engagement.
Compensation
- $50 to $70 per hour.
Vacancy posted 27 days ago
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