Senior Executive - Regulatory Affairs (Export Business)

Job Description

Company Description New Life Medicals is a group of entities with operations in the United States, India, and Ireland, specializing in the sourcing and supplying of APIs, bulk drugs, Reference listed Drugs, and Comparator drugs for Clinical Trial Study Across All Therapeutic Segments. The company has a strong sourcing network of suppliers from global markets and offers a range of pharmaceutical products for clinical trials and as white-labeled generics. Role Description This is a full-time on-site role for a Senior Executive in Regulatory Affairs (Export Business) at New Life Medicals located in Ahmedabad. The role involves handling regulatory documentation, ensuring compliance with regulatory requirements, preparing dossiers, and overseeing regulatory affairs related to export business operations. Essential Duties and Responsibilities: Act as a liaison with regulatory agencies to obtain necessary product licenses and approvals. Prepare and submit regulatory documents such as CTO, dossiers, Artwork and other required filings to regulatory authorities in compliance with applicable regulations. Coordinate with external consultants for regulatory submissions and documentation wherever required. Manage export documentation processes and maintain client communication related to regulatory requirements. Collaborate with third-party manufacturers to ensure timely availability of regulatory compliance-related documents. Prepare documentation for obtaining manufacturing licenses and product approvals. Monitor regulatory changes and provide training to internal teams on updated regulatory guidelines and compliance requirements. Maintain regulatory documentation and ensure timely renewal of licenses and permits. Show more Show less