Regulatory Affairs Expert - Remote
New York, New York County, New York, 10261, USA
Listed on 2026-10-16
-
Healthcare
Healthcare Compliance, Medical Science Liaison
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 ResponsibilitiesReview 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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