Area Of Responsibility To review quality and manufacturing end data for various in-house developed APIs for regulatory adequacy for compilation of Drug Master Files Registration Dossiers Amendments Variations Technical Data Package Open Parts of DMFs for In-House developed APIs and their updation to meet current regulatory requirements To review outsourced intermediates for regulatory adequacy to support Procurement Team in vendor selection To coordinate with Chemical Research Department Analytical Department Chemical manufacturing and Quality Assurance in generating data as per the requirements of regulatory agencies Regulatory support to Procurement Team and Regulatory Affairs-Pharma Ensure compliance to regulatory departmental guidelines To ensure reposition of API dossiers into central repository and to provide information about regulatory commitments in timely manner Deliverables Compilation of Drug Master Files Registration Dossiers Technical Data Packages Open Parts for In-House developed APIs and ensuring their updation Preparation of Regulatory Amendments Variations for smooth API supplies and responses to regulatory deficiencies Regulatory support to Chemical Research Department Analytical Department Chemical manufacturing Quality Assurance Procurement Team and Regulatory Affairs-Pharma Ensure reposition of regulatory database and compliance to departmental guidelines

📌 Research Manager (Gurugram)
🏢 Sun Pharmaceutical Industries
📍 Gurugram