Regulatory Affairs Specialist for AI Regulatory Docs
Overview
Remote contractor role focused on regulatory documentation for an AI-oriented project. You’ll apply deep regulatory expertise to evaluate, draft, and critique responses aligned with agency expectations. The work centers on clinical documentation review, CTD/eCTD structure, and interactions with health authorities, shaping how AI models learn from real-world regulatory input. You don’t need AI experience, just solid domain knowledge and precise written communication. Bold ICH guidelines, CTD/eCTD and health authority interactions in your day-to-day work.
What You'll Do6
- 1Author and assess evaluation tasks modeled on agency requests and sponsor responses to ensure regulatory alignment.
- 2Review clinical documents to verify substantiation, proper scoping of commitments, and readiness for regulatory scrutiny.
- 3Differentiate between solid and superficial responses, providing clear justifications for any gaps or deficiencies.
- 4Check for consistency across large document sets, spotting unsupported statements or conflicting claims.
- 5Give structured, evidence-based written feedback grounded in regulatory guidelines that colleagues can act on.
- 6Communicate complex regulatory concepts clearly in asynchronous written form and, when needed, verbally.
Requirements7
- 15+ years in regulatory affairs with clinical submissions responsibility at sponsor, CRO, or consultancy.
- 2Proven track record drafting or leading responses to health authority information requests in ongoing filings.
- 3Strong knowledge of ICH guidelines, CTD/eCTD formats, and practical expectations of at least one major regulator (FDA, EMA, MHRA, PMDA, or Health Canada).
- 4Ability to critically evaluate clinical or safety documents to flag regulatory risks, unsupported statements, and reviewer concerns.
- 5Exceptional written communication skills with clear, concise, and defensible regulatory reasoning.
- 6Degree in life sciences, pharmacy, medicine, or related field; RAC certification is a plus.
- 7Experience engaging with multiple regions or agencies or familiarity with AI-assisted regulatory tools is valued.
Who Should Apply
The ideal candidate is an experienced regulatory affairs professional with a background in clinical submissions and strong experience with ICH, CTD/eCTD, and health authorities. This role may be less suitable for anyone without sponsor, CRO, or consultancy experience or those who lack the ability to provide structured, regulatory-grounded feedback. Candidates often miss out if they cannot demonstrate concrete examples of responding to health authority information requests or if their written rationale lacks precision. Expect a fit check to weigh your ability to interpret complex documents and communicate regulatory reasoning clearly.
Salary Insight
$50 - $80/hr. Pay terms are discussed later and no numbers are omitted or added beyond the stated range.
Location
Required Skills
Application Tip
Highlight a concrete example of a health authority information request you authored a response for, emphasizing regulatory rationale and CTD/eCTD alignment to boost your fit score.
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How your application is processed
1Application received
Your resume and details are logged the moment you apply.
2ATS + eligibility screening
We check your profile against the role’s skills, seniority, and requirements.
3Employer sees qualified profiles only
Only candidates who clear screening move forward.
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