Formulation Regulatory Affairs Specialist

6 days ago


Bengaluru, India Biocon Full time

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



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