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Regulatory Affairs Expert - Remote

YO AI Labs

Job Description

Job Description

Job Title: Regulatory Affairs Specialist
Location: Remote
Job Type: Contract Job Description

We are seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing and evaluating regulatory documentation. The role involves assessing clinical documents, ensuring compliance with regulatory guidelines, identifying inconsistencies, and providing clear, evidence-based feedback to improve AI-generated regulatory content.

Key Responsibilities
  • Review and evaluate clinical and regulatory documentation.

  • Assess regulatory submissions and responses for accuracy and compliance.

  • Ensure adherence to ICH guidelines and CTD/eCTD requirements.

  • Identify regulatory risks, inconsistencies, and unsupported claims.

  • Prepare structured, guideline-based written feedback.

Required Qualifications
  • 5+ years of Regulatory Affairs experience in the pharmaceutical, biotech, or CRO industry.

  • Experience with clinical submissions , regulatory documentation, and health authority interactions.

  • Strong knowledge of ICH guidelines and CTD/eCTD structure.

  • Excellent analytical, critical thinking, and written communication skills.

  • Degree in Life Sciences, Pharmacy, Medicine, or a related field .

Vacancy posted 13 days ago
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