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Regulatory Affairs Specialist

1 month ago

Bengaluru, Karnataka, India Biocon Full time
Job Title: Formulation Regulatory Affairs

At Biocon, we are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team. This role will be responsible for ensuring compliance with regulatory requirements for our formulation products in the US market.

Key Responsibilities:

  • Prepare, review, and submit ANDA/ANDS filings in the US market, including modules.
  • Provide regulatory inputs to cross-functional teams during product development and manufacturing.
  • Stay up-to-date with regulatory guidelines and requirements in the US market.
  • Manage regulatory databases and publish regulatory dossiers in eCTD format.
  • Review technical documentations required for dossier submission.

Requirements:

  • Hands-on experience with ANDA/ANDS filing expertise.
  • Experience working in the pharmaceutical industry.
  • Strong knowledge of regulatory guidelines and requirements in the US market.
  • Excellent communication and collaboration skills.

What We Offer:

  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A competitive compensation package.

How to Apply:

Kindly share your CV with us, including your total experience, current CTC, total number of ANDA/ANDS filings, and notice period. We look forward to hearing from you