<ul><li>Handle new drug applications, renewals, variations, and post-approval changes as per regulatory requirements.</li><li>Ensure timely submission of drug master files (DMF), product registration applications, and license renewals.</li><li>Maintain regulatory documents, labeling requirements, and quality-related reports.</li><li>Ensure compliance with country-specific regulations, pharmacopoeial standards (IP, USP, BP, EP), and ICH guidelines.</li><li>Update Standard Operating Procedures (SOPs) and regulatory checklists in alignment with the latest regulations.</li><li>Liaise with regulatory agencies, health authorities, and certification bodies to ensure product compliance.</li><li>Respond to regulatory queries, deficiency letters, and audits in a timely manner.</li><li>Ensure regulatory compliance throughout the product lifecycle, including label updates, safety variations, and market expansion.</li><li>Monitor changes in global regulatory policies and assess their impact on product registration.</li></ul>

Drug Regulatory Affairs Executive