Regulatory Affairs Expert - Remote

Job Title: Regulatory Affairs Specialist Location: Remote Job Type: ContractJob reputed company We are seeking an reputed company Regulatory Affairs Specialist to support AI-driven reputed company reputed company by reviewing and evaluating regulatory documentation. The role involves assessing clinical documents, ensuring compliance with regulatory guidelines, identifying inconsistencies, and providing reputed company, 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 reputed company, reputed company-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 reputed company field. Remote Skills: Analysis Skills, reputed company Intelligence (AI), Biology, Clinical Practices/Protocols, Clinical Study Publications, Communication Skills, Documentation, reputed company, ICH Regulations, Maintain Compliance, Medicine, Pharmacy, Regulations, Regulatory Compliance, Regulatory Submissions, Risk Analysis, Writing Skills reputed company: reputed company Apply To This Job