Key Responsibilities:
- Preparation, review, and timely submission of ANDA in the US market.
- Deficiency and lifecycle management for the products filed in the US.
- Review of technical (developmental and plant) documentation required for dossier submission.
- Providing necessary regulatory inputs to different cross-functional teams (including CMO and CDMO projects) during different stages of product development and manufacturing.
- Publishing the necessary regulatory dossiers into eCTD format as per the country requirement.
- Maintaining the necessary regulatory databases concurrently as and when regulatory updates are received.
- Responsible for understanding the requirements related to US regulatory submissions.
