Acts as primary liaison between the company and drug regulatory authorities. Coordinates pre-submission meetings with CDSCO for new drug applications. Manages relationships with state drug controllers and licensing authorities. Handles import and export licensing, NOC applications, and drug controller approvals. Monitors CDSCO website and official gazette for new regulatory notifications. Manages manufacturing and loan license amendments with state licensing authorities. Prepares responses to inspection reports and show cause notices from authorities. Coordinates GMP inspection readiness and manages inspection schedules. Manages drug registration renewal schedules and maintains approval status database. Provides regulatory guidance to management on compliance and operational decisions. Coordinates with customs authorities for import documentation and clearances. Prepares compliance status reports and regulatory risk dashboards for management. Stays current with Drugs and Cosmetics Act amendments and CDSCO orders.