Regulatory Affairs Specialist

6 days ago


Bengaluru, Karnataka, India Biocon Full time
Job Description

About the Role:

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Biocon. As a key member of our regulatory affairs team, you will be responsible for ensuring that our products meet all necessary regulatory requirements in the US market.

Main Responsibilities:

  • Product Submission and Lifecycle Management: Prepare, review, and timely submit ANDA applications for products in the US market. Manage deficiencies and ensure compliance with regulations throughout the product lifecycle.
  • Technical Documentation Review: Review technical documentations required for dossier submission, including developmental and plant documentation.
  • Cross-Functional Collaboration: Provide regulatory inputs to cross-functional teams during product development and manufacturing stages.
  • eCTD Publishing: Publish regulatory dossiers in eCTD format as per country requirements.
  • Regulatory Database Management: Maintain concurrent regulatory databases based on received updates.
  • US Regulatory Requirements Understanding: Stay up-to-date on US regulatory submission requirements.

Qualifications:

M.Pharm/B.Pharm degree is required, with 6-10 years of experience in a similar role.



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