Position: Senior Regulatory Affairs Specialist
Designation: Mumbai
Prepare documentation and submit them to the related distributors or authorized representatives to file to the authorities. Prepare and submit documentation to respond to additional requirements by authorities. Liaison and negotiate with related distributors or authorized representatives to proceed with projects. Communicate and collaborate with Regulatory Affairs members Devise submission strategy for new products to get clearance earlier. Keep abreast of legislation, guidelines, and regulations relating to regulatory affairs for each of countries; inform and advise Japan. Ensure that products and related documents conform to the latest appropriate medical product regulations. Monitor expiration dates of licenses and apply for license renewals. Respond to audits by authorities as needed.