Regulatory Officer

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 followups 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 followup 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: 35 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