Regulatory officer

Responsibilities:

1.Liaise with principal companies for all registration & regulatory matters of the products.

2. Preparation & submission of dossiers to register new products with Ministry of Health. 3.Preparation & submission of files for registration of companies in MOH.

4.Preparation and submission of files to obtain approvals for post-approval variations of products.

5.Preparation and submission of file for the registration of “a brand” under Pharma & Medical Equipment Department as & when required.

6.Manage to get approval from KDFC-MOH for the transfer of commercial goods to Free Medical Samples as and when needed by business partner.

7. Ensure to timely submit the files to renew the product licenses with MOH.

8.Preparation and submission of documents to get approval for advertisements from Kuwait Drug & Food Control, MOH.

9.Ensure to timely renew the registrations of MOH.

10. Follow-up with KDFC QC Lab. for timely analysis of products & releases of invoices and arrange for them reference standards as and when needed.

11. Arrange to get import permits as and when required for importing of restricted reference standards for KDFC QC Lab.

12. Timely reporting of safety reports to business partners & submissions of ICSRs/ADRS to KDFC-MOH.

13.Timely fulfillment of all PV related obligations of business partners & KDFC-MOH.

14.Prepare reports required by Sr. Manager Regulatory, PV & MOH Tenders or Assistant Manager Regulatory Affairs & PV.

15. Perform ad-hoc and other duties related to the job as assigned by Sr. Manager Regulatory, PV & MOH Tenders and Assistant Manager Regulatory & PV.

16. Ensure to update the Pharm & Medical Equipment Department about any changes in MOH fixed prices.

17. Ensure proper archiving and retrieval of all regulatory documents.

Requirements:

-Bachelor degree in Pharmacy

-Transferrable residency

-Kuwaiti driving license

-1- 3 years' experience

-Bilingual - Arabic / English

-Regulatory Experience is a must.