Executive

1. Responsible for preparation of applications of ANDA, IND, NDA in USFDA and other regulatory bodies.2. Uploading documents in e-CTD compilation, handling Lorenz validation, TVT software, monitoring the queries received, and responding in a timely manner. Controlling correspondence with FDA.3. Prepare and submit post approval amendments in applications, executive summaries for regulatory submissions.4. Monitor the progress of review of application and approval in collaboration team.5. Provide regulatory inputs to the cross-functional technical team.