<ul><li>Lead regulatory affairs activities for product registrations, approvals, and compliance.</li><li>Prepare, review, and submit regulatory dossiers (CTDs, DMFs, ANDAs, etc.) to global authorities.</li><li>Ensure adherence to regulatory guidelines (USFDA, EMA, MHRA, WHO, CDSCO, etc.).</li><li>Coordinate with R&amp;D, QA, QC, and Production teams for data collection and submissions.</li><li>Handle regulatory queries, deficiency letters, and ensure timely responses.</li><li>Monitor changes in global regulations and ensure company compliance.</li><li>Support regulatory inspections, audits, and internal compliance reviews.</li><li>Develop and maintain regulatory documentation and databases systematically.</li></ul>

Regulatory Affairs Manager