information technology (IT) analyst
Title posted on Talent.com - Regulatory Affairs Specialist
Posted on September 22, 2026 by Employer details RemoteJobsOne
Job details
<p><strong>This is a fully remote position</strong>, open to candidates based in Canada.</p><p><strong>Pay:</strong> $50?$80/hr</p><p>Role Title: Regulatory Affairs Specialist</p><p>Role Type: Contractor</p><p>Location: Remote</p><p>We are engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required ? your domain knowledge is what matters.</p><p>Scope of Work</p><ol><li>Author and review evaluation tasks inspired by real-world agency requests and sponsor response threads, determining if drafted responses meet regulatory expectations.</li><li>Apply expert judgment to review clinical documentation, assessing whether conclusions are substantiated, commitments are properly scoped, and records can withstand regulatory scrutiny.</li><li>Distinguish between substantively adequate and superficially polished responses, articulating clear rationales for any deficiencies.</li><li>Assess consistency across comprehensive document sets, identifying unsupported or conflicting claims within or between documents.</li><li>Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines rather than subjective impressions.</li><li>Collaborate asynchronously and communicate complex regulatory concepts clearly in both written and verbal form.</li></ol><p>Preferred Qualifications</p><ol><li>5+ years of direct regulatory affairs experience at a sponsor, CRO, or consultancy, with responsibility for clinical submissions.</li><li>Documented experience drafting or leading responses to health authority information requests, particularly for ongoing regulatory filings.</li><li>Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada).</li><li>Proven ability to critically read clinical or safety documents to identify regulatory risks, unsupported statements, and potential reviewer concerns.</li><li>Exceptional written communication skills, with the capability to convey regulatory reasoning clearly, concisely, and defensibly.</li><li>Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.</li><li>Experience engaging with multiple regions or agencies, prior health authority reviewer/assessor background, or familiarity with AI-assisted regulatory tools (all considered valuable).</li></ol> <p><strong>How to apply</strong></p> <p>Apply here with your Indeed profile. We will then email you a link to complete your application on the hiring platform ? your application is only considered once that final step is done.</p>- Location Toronto, ON
- Work location On site
- Salary$50.00 to $80.00HOUR hourly
- Terms of employment Full time
- Starts as soon as possible
- vacancies 1 vacancy
- Source Talent.com #638480900414770936
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