Prepares and submits drug registration dossiers to CDSCO and state drug authorities. Compiles CTD and ACTD format submissions for new drug applications. Coordinates with R&D, clinical, and manufacturing for regulatory documentation. Tracks submission status and follows up with regulatory authorities for approvals. Prepares responses to deficiency letters and queries from drug authorities. Maintains regulatory databases and tracks product approval timelines. Ensures labeling, package inserts, and artwork comply with regulatory requirements. Supports international regulatory submissions for export and ROW markets. Monitors changes in drug regulations and advises product development teams. Manages product renewals, variations, and post-approval changes effectively. Prepares regulatory strategy documents for new product development pipeline. Coordinates with legal team for trademark, patent, and IP-related matters. Stays updated with CDSCO, WHO, ICH guidelines, and global regulatory changes.