Job Description
- To review of 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 of outsourced APIs for regulatory adequacy to support Procurement and Regulatory Affairs-Pharma in connection with Drug products filings for Regulatory adequacy
- To coordinate with Chemical Research Division, Analytical Department and Manufacturing locations in generating data as per the requirements of regulatory agencies
- To ensure reposition of API dossiers into central repository and to provide information about regulatory commitments in timely manner