Formulation Regulatory Affairs Specialist

1 week 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.PharmExperience: 8 Years to 12 Years

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