Jobs / Day Shift Jobs / Regulatory officer

Regulatory officer

Ali Abdulwahab Al Mutawa Commercial Co - Kuwait - Kuwait
Employment: Full Time
Responsibilities:


  • Liaise with principal companies for all registration & regulatory matters of the products.
  • Preparation & submission of dossiers to register new products with Ministry of Health. 3.Preparation & submission of files for registration of companies in MOH.
  • Preparation and submission of files to obtain approvals for post-approval variations of products.
  • Preparation and submission of file for the registration of “a brand” under Pharma & Medical Equipment Department as & when required.
  • Manage to get approval from KDFC-MOH for the transfer of commercial goods to Free Medical Samples as and when needed by business partner.
  • Ensure to timely submit the files to renew the product licenses with MOH.
  • Preparation and submission of documents to get approval for advertisements from Kuwait Drug & Food Control, MOH.
  • Ensure to timely renew the registrations of MOH.
  • Follow-up with KDFC QC Lab. for timely analysis of products & releases of invoices and arrange for them reference standards as and when needed.
  • Arrange to get import permits as and when required for importing of restricted reference standards for KDFC QC Lab.
  • Timely reporting of safety reports to business partners & submissions of ICSRs/ADRS to KDFC-MOH.
  • Timely fulfillment of all PV related obligations of business partners & KDFC-MOH.
  • Prepare reports required by Sr. Manager Regulatory, PV & MOH Tenders or Assistant Manager Regulatory Affairs & PV.
  • Perform ad-hoc and other duties related to the job as assigned by Sr. Manager Regulatory, PV & MOH Tenders and Assistant Manager Regulatory & PV.
  • Ensure to update the Pharm & Medical Equipment Department about any changes in MOH fixed prices.
  • 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.
Apply on the Job Website
Post date: 18 September 2024
Publisher: LinkedIn
Post date: 18 September 2024
Publisher: LinkedIn