Drug Regulatory Officer

Job Summary: We are looking for a knowledgeable and detail-oriented Drug Regulatory Officer to oversee regulatory compliance related to pharmaceutical products. The candidate will ensure that all drugs and related documentation comply with national and international regulations, support product approvals, and maintain up-to-date records with regulatory authorities. Key Responsibilities:Prepare, review, and submit applications/dossiers to regulatory authorities (DCGI, CDSCO, FDA, etc.). Ensure compliance with applicable laws, regulations, and guidelines in the pharmaceutical industry. Maintain and update product registration files, licenses, and regulatory documentation. Monitor and interpret regulatory requirements, policies, and changes in legislation. Liaise with regulatory bodies and respond to queries in a timely manner. Coordinate with R&D, QA, QC, and manufacturing teams to ensure compliance during product development and production. Assist in audits, inspections, and ensure documentation is always audit-ready. Prepare regulatory strategies for new product launches.