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Regulatory Officer
Location:
Ahmedabad, Gujarat
Description:
Company Profile: Our Client company is Denmark based and they have impacted people around the world with there products and services. As one of the world's largest pharmaceutical wholesalers, There Repackaging unit is in Gandhidham. Job Profile: The position will be Responsible for: 1. Request, follow-ups and obtain product dossier from the manufacturer where applicable. 2. Assess and report deficiencies to the manufacturer and recollect documentation as appropriate, also to escalate internally and report to manager. 3. Prepare and submit registration dossiers as per CTD/Country specific requirement with layout review for submission. 4. Completion and ensure dossiers submission in targeted timeline. 5. Dispatch of registration dossiers to the National Drug Regulatory Authorities (NDRA)/agents as applicable. 6. Actively finding solutions on queries/feedback from NDRA/agent for supplier’s having difficulties in meeting the requirement. 7. Request and follow-up on samples required for submission. 8. Status updates on MP connect Registration and NDRA overview. 9. Coordinate with MP agents and Country Managers on handling regulatory submission and update on country guidelines. Process the payment for dossier submission. 10. Review of technical documents/dossiers as per country requirement to ensure quality submission with zero query. 11. Response to query received from NDRA on priority. 12. Smooth initiation of renewal/retention process for different countries and ensure timely submission. 13. Filing of variation in different countries as applicable 14. Ensure that database is maintained updated reflecting actual activity, organize meetings and report to manager. 15. Any other duties or assignments as requested by the manager Desired Candidates: Education: Pharmacist, Bachelor/master’s in pharmacy. Work Experience: 3-5 years of experience in regulatory functions from pharmaceutical organizations. Knowledge of ROW market and regulatory experience in medical devices is preferred. Contact Person: Rina Arun / Srushti raval XXXX@uhr.co.in
Posted:
April 22 on iSmartRecruit
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Regulatory Officer is a Science, Pharmaceutical & Biotech Jobs Regulatory Officer Job located in Ahmedabad GJ. Find other listings like Regulatory Officer by searching Oodle for Science, Pharmaceutical & Biotech Jobs Regulatory Officer Jobs.
Regulatory Officer is a Science, Pharmaceutical & Biotech Jobs Regulatory Officer Job located in Ahmedabad GJ. Find other listings like Regulatory Officer by searching Oodle for Science, Pharmaceutical & Biotech Jobs Regulatory Officer Jobs.