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Regulatory Affairs Expert - Remote
Remote / Online - Candidates ideally in
Miami, Colfax County, New Mexico, 87729, USA
Listed on 2026-08-22
Miami, Colfax County, New Mexico, 87729, USA
Listing for:
YO AI Labs
Remote/Work from Home
position Listed on 2026-08-22
Job specializations:
-
Healthcare
Healthcare Compliance, Medical Science Liaison
Job Description & How to Apply Below
Job Title:
Regulatory Affairs Specialist
Location:
Remote
Job Type: Contract
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.
- 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.
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