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Job highlights

Work/Life Balance

Time management

challenging projects

Insurance

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.

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