Regulatory Compliance Specialist

4 days ago


Dholka, Gujarat, India beBeeRegulatory Full time ₹ 60,00,000 - ₹ 1,20,00,000

Key responsibilities for this role include:

  • Preparing and submitting registration and re-registration dossiers as per country requirements.
  • Submitting various original documents for notarization, chamberization, and legalization.
  • Coordinating with other departments to ensure timely filings and query responses.
  • Post-approval activities, including submission of variations to marketing authorizations.
  • Preparing Certificate of Pharmaceutical Products (COPPs) and Field Safety Corrections (FSCs) for Local FDA approvals.
  • Enhancing self-awareness about changing regulatory requirements in the pharmaceutical industry.
About Regulatory Compliance

This position requires a blend of technical expertise, communication, project management, and analytical skills to navigate the complex regulatory landscape.

A successful candidate will have experience in pharmaceutical industries in African markets, possessing M. Pharma/B.Pharma degree.

Qualifications

M. Pharma/B.Pharma degree required.

Requirements

Experience in pharmaceutical industries in African markets is essential.



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