REGULATORY AFFAIRS & IMPORTATION EXECUTIVE

Application deadline closed.

Job Description

JOB BRIEF

Responsible for all Product Classification/Manufacturing Site Registration and Product Registration and to ensure that all documents required are available and are submitted on time. They are also responsible for the preparation of the pre- and final perm

Policies & Procedures:

  • Adhere to all Zahrawi Policies & Procedures as applicable.

Regulatory Affairs:

  • Ensure that Zahrawi’s products comply with the regulations of the MOH.
  • Keep up to date with the latest changes in regulatory legislation and guidelines.
  • Liaise and negotiate with regulatory authority to ensure a smooth registration process.

Product Classification & Registration:

  • Ensure that all required documents and actions for Product Classification/Manufacturing Site Registration and Product Registration are available.
  • Prepare all required documents to be submitted for Product Classification under MOH.
  • Prepare all required documents to be submitted for Manufacturing Site registration under MOH.

Importation Permits:

  • Prepare and apply for the pre-permit document as per the MOH guidelines and verify the items being imported and the documents required.
  • Communicate with the existing and new suppliers regarding MOH importation rules and policies.
  • Upload on the MOH importation system any new classifications or registration certificates.

Audit:

  • Prepare any documentation needed for internal and external audits.
  • File all documents in the corresponding files to ensure all are available and are correct.
  • Evaluate the suggestions after the audit and implement them when possible.

Pharmacovigilance System:

  • Responsible for Pharmacovigilance related work and assigned as deputy QPPV.
  • Report Adverse Drug Reactions (ADRs) for all products by collating the needed information and incorporating customer’s comments.
  • Conduct monthly PV activities to keep full compliance with the regulations.
  • Prepare and review all SOP’s Pharmacovigilance plans for all Zahrawi Suppliers.

Medical Devices FSN/FSA Vigilance system:

  • Report the received FSN/FSA to the health Authority and keep align with the reporting timelines.
  • Keep tracking for the reported cases and the health Authority requirements to ensure fulfillment.
  • Keep updated with the new regulations related to the local vigilance system and report them to the manager

REQUIREMENTS

  • Education: Bachelors Degree
  • Additional details:
    • Candidates must be based in the UAE and should be willing to move to company visa 
    • Candidates must have a valid MOH license
  • Experience: 2 – 4 years of experience.
  • Job Specific Skills: Require a good knowledge in  Pharmacist, Regulatory Affairs, Importation Permits
Area
Dubai