Key Responsibilities
- Preparation, review, and timely submission of ANDA in US market.
- Deficiency and life cycle management for the products filed in US.
- Review of technical (developmental and plant) documentations 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 on when regulatory updates are received.
- Responsible to understand the requirements related to US regulatory submissions.
Qualification: M.Pharm/B.Pharm
Experience: 8 Years to 12 Years