Act as a liaison with regulatory agencies to obtain necessary product licenses and approvals.Prepare and submit regulatory documents such as CTO, CTD, ACTD, eCTD, dossiers, and other required filings to regulatory authorities in compliance with applicable regulations.Coordinate with external consultants for regulatory submissions and documentation wherever required.Manage export documentation processes and maintain client communication related to regulatory requirements.Collaborate with third-party manufacturers to ensure timely availability of regulatory compliance-related documents.Prepare documentation for obtaining manufacturing licenses and product approvals.Monitor regulatory changes and provide training to internal teams on updated regulatory guidelines and compliance requirements.Maintain regulatory documentation and ensure timely renewal of licenses and permits.Education
Master of Pharmacy (M.Pharm), Bachelor Of Pharmacy (B.Pharm)
Skills Required
Regulatory, global markets , Crm, Good Communication