<ul><li>Prepare, review, and submit regulatory documents for product approvals and licenses.</li><li>Ensure compliance with national and international regulatory guidelines (CDSCO, USFDA, EMA, etc.).</li><li>Maintain product registration dossiers and technical files.</li><li>Coordinate with R&amp;D, QA, QC, and production teams for regulatory submissions.</li><li>Monitor changes in regulatory requirements and update documentation accordingly.</li><li>Handle regulatory queries, audits, and inspections effectively.</li><li>Ensure timely renewal of licenses, registrations, and certifications.</li><li>Review labeling, packaging, and promotional material for regulatory compliance.</li><li>Assist in compiling data for ANDA, DMF, CTD, and eCTD submissions.</li></ul>

Regulatory Affairs Officer