<ul><li>Prepare, review, and compile regulatory dossiers for oral solid dosage (OSD) products.</li><li>Ensure timely submission of DMFs, ANDAs, CTDs, and other regulatory documents.</li><li>Maintain up-to-date knowledge of global regulatory requirements (USFDA, EMA, MHRA, WHO, etc.).</li><li>Coordinate with R&amp;D, QA, QC, and Production teams for data collection and dossier preparation.</li><li>Review technical documents such as PDR, stability data, and validation reports.</li><li>Handle regulatory queries, deficiency letters, and ensure timely responses.</li><li>Track product registrations, renewals, and post-approval changes.</li><li>Support in preparation for audits and regulatory inspections.</li><li>Ensure compliance with company policies and international guidelines.</li></ul>

Regulatory Affairs (OSD)