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.
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.
Regulatory Affairs Expert - Remote • Dallas, TX, USA
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