Regulatory Affairs Expert - Remote
YO AI Labs
Miami, NM
- Remote job
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. 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. #J-18808-Ljbffr YO AI Labs
Vacancy posted 2 days ago
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