Regulatory Affairs Specialist - Remote

<strong>Job Title:</strong> Regulatory Affairs Specialist<br><br><strong>Location:</strong> Remote<br><br><strong>Job Type:</strong> Contract<br><br><strong>Job Description<br><br></strong>We are seeking an experienced <strong>Regulatory Affairs Specialist</strong> 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.<br><br><strong>Key Responsibilities<br><br></strong><ul><li>Review and evaluate clinical and regulatory documentation. </li><li>Assess regulatory submissions and responses for accuracy and compliance. </li><li>Ensure adherence to ICH guidelines and CTD/eCTD requirements. </li><li>Identify regulatory risks, inconsistencies, and unsupported claims. </li><li>Prepare structured, guideline-based written feedback. <br><br><br></li></ul><strong>Required Qualifications<br><br></strong><ul><li>5+ years of Regulatory Affairs experience in the pharmaceutical, biotech, or CRO industry. </li><li>Experience with clinical submissions, regulatory documentation, and health authority interactions. </li><li>Strong knowledge of ICH guidelines and CTD/eCTD structure. </li><li>Excellent analytical, critical thinking, and written communication skills. </li><li>Degree in Life Sciences, Pharmacy, Medicine, or a related field.</li></ul>