Regulatory Affairs Specialist

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.