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This is a fully remote position , open to candidates based in Italy.
Pay: $50–$80/hr
Role Title: Regulatory Affairs Specialist
Role Type: Contractor
Location: Remote
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.
Scope of Work
- Author and review evaluation tasks inspired by real-world agency requests and sponsor response threads, determining if drafted responses meet regulatory expectations.
- Apply expert judgment to review clinical documentation, assessing whether conclusions are substantiated, commitments are properly scoped,



and records can withstand regulatory scrutiny.
- Distinguish between substantively adequate and superficially polished responses, articulating clear rationales for any deficiencies.
- Assess consistency across comprehensive document sets, identifying unsupported or conflicting claims within or between documents.
- Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines rather than subjective impressions.
- Collaborate asynchronously and communicate complex regulatory concepts clearly in both written and verbal form.

Preferred Qualifications
- 5+ years of direct regulatory affairs experience at a sponsor, CRO, or consultancy, with responsibility for clinical submissions.
- Documented experience drafting or leading responses to health authority information requests, particularly for ongoing regulatory filings.
- Demonstrated working knowledge of the ICH frame

📌 Regulatory Affairs Specialist (Roma)
🏢 RemoteJobsOne
📍 Roma