<ul><li>Relevant experience in API Regulatory Affairs.</li><li>Preparation of US DMF, CEP in eCTD and preparation of ASMF.</li><li>Should have through knowledge in ICH and other regulatory guidelines through knowledge of control strategy is essential.</li><li>Hands on experience for query response for the relevant competitive authority ( US FDA ).</li><li>Review and compilation of data required for regulatory submissions to various regulatory authorities response to the customer queries with consultation with manager regulatory affairs.</li><li>Update the knowledge as per recent guidelines to cater the requirement while compilation of regulatory submissions.</li></ul><p><br></p>

Assistant Manager / Deputy Manager - Regulatory Affairs ( API )