Regulatory Affairs Specialist - Remote

Job DescriptionJob DescriptionJob Title: Regulatory Affairs SpecialistLocation: RemoteJob Type: ContractJob DescriptionWe 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.Required Qualifications5+ 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.