Regulatory Affairs Specialist

4 days ago


Bengaluru, Karnataka, India Biocon Full time

As a Regulatory Affairs Specialist with Biocon, you will be responsible for preparing and reviewing ANDA/ANDS applications for the US market. This role requires a deep understanding of life cycle management for products filed in the US market.

About the Role

The ideal candidate will have hands-on experience with preparation, review, and submission of ANDA/ANDS in the US market. Additionally, they should possess comprehensive knowledge on regulatory guidelines and requirements.

Key Responsibilities:

  • Preparing and reviewing ANDA/ANDS applications for the US market
  • Maintaining regulatory databases and publishing regulatory dossiers into eCTD format
  • Reviewing technical documents required for dossier submission
  • Providing necessary regulatory inputs to cross-functional teams during product development and manufacturing stages

Requirements:

  • Hands-on ANDA/ANDS filing expertise
  • A stable background in pharmaceutical regulations
  • Experience with US submissions
  • Well-versed with regulatory guidelines

What We Offer:

We offer an estimated salary range of $90,000 - $140,000 per year, depending on experience.



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