<ul><li>Compilation, review and submission of DMF as per the current regulatory requirements to regions US, Europe, EDQM and ROW.</li><li>Preparing and submitting responses to queries from customers.</li><li>Plant regulatory support by ensuring life cycle management and pharmacopoeia evaluation.</li><li>Compilation and submission of Amendments to USFDA, filing of revisions to Europe.</li><li>Maintaining and tracking the regulatory activities on-line.</li><li>Handling Change Control Forms.</li><li>Coordinating with other departments in obtaining documents for compilation.</li><li>Defining control strategies for impurities based on updated guidance.</li></ul>

Executive / Senior Executive - Regulatory Affairs ( API )