Regulatory Affairs Specialist, AI Healthcare & ICH Guidelines
Overview
Own regulatory documentation review for AI-driven healthcare projects, ensuring clinical and regulatory submissions meet ICH and CTD/eCTD standards. Collaborate with cross-functional teams to validate AI-generated content, reducing compliance risk across global submissions. This remote contract role focuses on evidence-based feedback, not routine document processing.
What You'll Do8
- 1Review clinical and regulatory documentation for AI-driven healthcare projects, flagging risks and inconsistencies.
- 2Assess regulatory submissions and responses for accuracy and compliance with ICH guidelines and CTD/eCTD requirements.
- 3Identify regulatory gaps, unsupported claims, and inconsistencies in AI-generated content, providing clear, evidence-based feedback.
- 4Prepare structured, guideline-based written feedback for AI model improvement and regulatory alignment.
- 5Collaborate with regulatory teams to ensure documentation aligns with health authority expectations and submission standards.
- 6Drive compliance checks on regulatory content, using CTD/eCTD structure to flag missing or misaligned sections.
- 7Map regulatory risks to specific guidelines, delivering actionable recommendations to technical teams.
- 8Own the feedback loop for AI-generated regulatory documents, ensuring iterative improvements meet ICH standards.
Requirements8
- 15+ years of Regulatory Affairs experience in pharmaceutical, biotech, or CRO environments.
- 2Experience with clinical submissions and regulatory documentation, including health authority interactions.
- 3Strong knowledge of ICH guidelines and CTD/eCTD structure.
- 4Demonstrated ability to assess regulatory documents for accuracy, consistency, and compliance.
- 5Proven track record of delivering clear, structured written feedback on regulatory content.
- 6Degree in Life Sciences, Pharmacy, Medicine, or related field.
- 7Strong analytical and critical thinking skills, applied to regulatory evaluation.
- 8Excellent written communication, with capability to articulate regulatory findings.
Salary Insight
$104 - $166k per year
Location
Required Skills
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