Regulatory Affairs Specialist

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This is a fully remote position open to candidates based in Canada.

Pay: $50$80/hr

Role Title: Regulatory Affairs Specialist

Role Type: Contractor

Location: Remote

We are engaging Regulatory Affairs Specialists to contribute to a customers project focused on AI innovation in regulatory this role youll 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

1. Author and review evaluation tasks inspired by real-world agency requests and sponsor response threads determining if drafted responses meet regulatory expectations.
2. Apply expert judgment to review clinical documentation assessing whether conclusions are substantiated commitments are properly scoped and records can withstand regulatory scrutiny.
3. Distinguish between substantively adequate and superficially polished responses articulating clear rationales for any deficiencies.
4. Assess consistency across comprehensive document sets identifying unsupported or conflicting claims within or between documents.
5. Provide structured well-reasoned written feedback grounded in applicable regulatory guidelines rather than subjective impressions.
6. Collaborate asynchronously and communicate complex regulatory concepts clearly in both written and verbal form.

Preferred Qualifications

1. 5 years of direct regulatory affairs experience at a sponsor CRO or consultancy with responsibility for clinical submissions.
2. Documented experience drafting or leading responses to health authority information requests particularly for ongoing regulatory filings.
3. 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).
4. Proven ability to critically read clinical or safety documents to identify regulatory risks unsupported statements and potential reviewer concerns.
5. Exceptional written communication skills with the capability to convey regulatory reasoning clearly concisely and defensibly.
6. Degree in life sciences pharmacy medicine or a related field; RAC certification is an advantage.
7. Experience engaging with multiple regions or agencies prior health authority reviewer/assessor background or familiarity with AI-assisted regulatory tools (all considered valuable).

How to apply

Apply here with your 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.