- To have knowledge of ICH guidelines and other regional regulatory requirements including USFDA, EMA, NMPA, TGA, CADIFA and other global regulatory market.
- To compile and Review of Drug Master file as per country-specific regulatory requirements.
- To Prepare, review, and submit DMF amendments in accordance with applicable regulatory requirements.
- To Prepare and submit responses to regulatory authority queries within defined timelines.
- To Evaluate change control proposals and classify changes as per regional regulatory guidelines.
- To Coordinate effectively with cross-functional teams (QA, QC, ADL, R&D;, Manufacturing, etc.).
- To Organize cross-functional meetings and prepare Minutes of Meeting (MoM).
- To have knowledge regarding genotoxic impurity evaluation and Nitrosamine risk assessment as per current regulatory requirement.
- To manage lifecycle management activities of regulatory products.
- To Communicate with customers regarding regulatory changes and change notifications.