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Regulatory Officer

3 months ago

Ahmedabad, Gujarat, India United HR Solution Full time

Company Profile:

Our Client company headquartered in Denmark has made a global impact with their range of products and services. They are known as one of the largest pharmaceutical wholesalers with a Repackaging unit located in Gandhidham.

Job Profile:

  • Request followups and obtain product dossier from the manufacturer where applicable.
  • Assess and report deficiencies to the manufacturer, recollect documentation, and escalate internally.
  • Prepare and submit registration dossiers according to specific requirements with layout review for submission.
  • Ensure timely completion and submission of dossiers.
  • Dispatch registration dossiers to National Drug Regulatory Authorities (NDRA)/agents.
  • Find solutions to queries/feedback from NDRA/agents for suppliers facing challenges.
  • Request and followup on samples required for submission.
  • Provide status updates on MP connect Registration and NDRA overview.
  • Coordinate with MP agents and Country Managers for regulatory submission and guidelines adherence. Process payment for dossier submission.
  • Review technical documents/dossiers as per country requirements to ensure quality submission with zero queries.
  • Respond to queries from NDRA promptly.
  • Initiate renewal/retention process for different countries and ensure timely submission.
  • File variation in different countries as applicable.
  • Maintain an updated database, organize meetings, and report to the manager.
  • Perform any other duties or assignments as requested by the manager.

Desired Candidates:

Education: Pharmacist Bachelor/master's in pharmacy.

Work Experience: Minimum 3-5 years of experience in regulatory functions in pharmaceutical organizations. Preferably familiar with the ROW market and regulatory practices in medical devices.