Regulatory Affairs Associate

2 weeks ago


Ahmedabad, Gujarat, India Medical Device Manufacturing Full time
International Regulatory Affairs Executive

The International Regulatory Affairs Executive will be responsible for preparing and submitting regulatory dossiers for pharmaceutical products in Rest of the World (ROW), Asian, and African markets.

Key Responsibilities:
  • Dossier Preparation & Submission:
    • Ensure timely preparation and submission of dossiers, including CTD, ACTD, and country-specific formats.
  • Regulatory Compliance & Documentation:
    • Maintain up-to-date knowledge of international regulatory guidelines (ICH, WHO, country-specific regulations).
    • Ensure compliance with regulatory requirements for product registration, renewals, and variations.
    • Prepare and review technical documents, including stability data, product formulation, and analytical reports.
  • Coordination & Communication:
    • Liaise with internal departments such as R&D, Quality Assurance, Quality Control, and Production to collect required documents.
    • Communicate with regulatory authorities and clients to address queries and ensure smooth approval processes.
  • Regulatory Intelligence & Updates:
    • Monitor and update changes in regulatory guidelines for ROW, Asian, and African markets.
    • Implement necessary updates in documentation and processes to align with regulatory changes.


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