<ul><li>Lead and oversee regulatory submissions for domestic and international markets.</li><li>Prepare, review, and approve dossiers (CTD/eCTD) for product registrations, renewals, and variations.</li><li>Ensure compliance with regulatory requirements of agencies like USFDA, EMA, MHRA, WHO, and CDSCO.</li><li>Liaise with health authorities and respond to regulatory queries on time.</li><li>Coordinate with cross-functional teams (R&amp;D, QA, QC, Production) for data collection and document management.</li><li>Review and approve labeling, packaging, and promotional materials for regulatory compliance.</li><li>Manage regulatory strategy for new product development and lifecycle management.</li><li>Train and guide junior executives in regulatory processes and best practices.</li></ul>

Asst. Manager/Manager-Regulatory Affairs