Regulatory Affairs & Warehouse Pharmacist
| Company Name: | Zahrawi Group |
| Employment Type: | Full Time |
| Location: | Dubai |
| Experience: | 2-4 years |
| Degree: | Bachelor |
| Gender: | Any |
| Age: | Any |
| Nationality: | Any |
| Salary: | Unspecified |
| No. Of Vacancies: | 1 |
| 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 |
