Regulatory Affairs & Warehouse Pharmacist

The incumbent is 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 permits for the imported items as per the MOH guidelines.

ACCOUNTABILITIES

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.
• Provide advice about regulations to customers/suppliers.
• Analyze product complaints and make recommendations to solve the problem and to avoid them in the future.

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.
• Prepare all the Dossiers to be submitted to MOH for product registration.
• Collect all necessary documents from Supplier to submit for Ministry of Environment.

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.
• Apply for the MOH regulated products permits on the MOH website as per the specified guidelines.
• Register and submit the permits for Ministry of Environment.
• Apply for the final approval of the items being shipped through the MOH, once shipments received to the port and coordinate with logistic team for the same.
• Resubmit any permits that have not been approved and make sure all the information provided is correct and attach any new documents if required.
• Prepare daily report regarding the rejections/ delays for MOH importation permits and reasons related to that. 

Importation Rules & Regulations:

• 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.
• Ensure that all urgent request from the Sales team and suppliers are dealt with in a fast manner and ensure that all documents are in place.
• Report any deviation from MOH guidelines of imported shipments and take the corrective and preventive action accordingly.
• Review on a regular basis the MOH importation process of distribution agreements.
• Ensure that the MOH license is renewed before expiry date to avoid importation disturbance.
• Segregate the imported products as per HS code in coordination with logistic team and confirm if products are MOH regulated or not.
•  Coordinate with the Procurement & Logistics Team to update all the required documents in time to avoid importation rejections.

Pharmacovigilance:

•  Responsible for all Pharmacovigilance related work and assigned as the LRPPV (Local Responsible Person for Pharmacovigilance)
• Perform regulatory intelligence by screening the MOH websites on a weekly basis.
• Screen all scientific and medical literature to stay up to date with the latest regulations.
• Comply with local regulatory requirements for reporting adverse drug reactions and submission of safety reports.
• Report Adverse Drug Reactions (ADRs) for all products by collating the needed information and incorporating customer’s comments.
• Fill the Council for International Organizations of Medical Sciences (CIOMS) forms with all the information collected from the ADRs.
• Send all CIOMS forms to the Manufacturers and the relevant authorities.
• Manage the Pharmacovigilance process of Zahrawi by and prepare all SOPs, product safety reviews and literature reviews when needed.
• Maintain a high level of standard to ensure that all work is moving smoothly and that there are no delays.
• Prepare and review all SOP’s Pharmacovigilance plans for all Zahrawi Suppliers.
• Prepare all Registration and Pharmacovigilance forms and communicating the same to the Suppliers and stakeholders.
• Provide trainings to all internal divisions on the current Pharmacovigilance Policies & Procedures.

Individual Case Study Reports (ICSRs):

• Report any spontaneous Individual Case Study Reports (ICSRs) to the Supplier and the Health Authority.
• Maintain a soft and hard copy of all ICSRs for the future.
• Track and follow up with all active ICSR reconciliation with the respective authorities.
• Report all Suspected and Unexpected Serious Adverse Reactions to relevant Health Authorities.

Quality Assurance:

• Monitor all Cold Products from point of receiving until delivery of products to customers along with Data Logger results within the set temperature limits.
• Examine the packing of goods from the cold storage and monitor the Data Logger Report to ensure consistency.
• Check the quality of the vehicles, warehouse cleanliness, temperature control mechanism, storage conditions and validity of goods on shelves on a regular basis. 
• Ensure all Zahrawi Cold Vans/Delivery Vehicles, Data Loggers are calibrated regularly and update the temperature mapping of the Warehouse.
• Ensure all required licenses and registrations as well as calibration renewals are updated before their expiry dates.
• Review all technical and quality agreements with suppliers and customers on a regular basis.

Warehouse Quality Check:

• Ensure that the Warehouse & Service Room are kept clean and organized.
• Ensure that the temperature control mechanism and hygiene standards are maintained in the Warehouse.
• Ensure a quick and accurate release of shipments from MOH to avoid any delays in transporting the products to the customer.
• Ensure that all stock areas are segregated properly into: Dispatching, Receiving, Returns, Hold and Expired and that no mix-up could happen at any time.

Product Quality Check:

• Ensure that a sample of each batch of products is secured from the WH Assistants and provide the samples along with a progress report and supplier invoice to the Warehouse Operation, QA & RA Manager for MOH release approval.
• Check all shipments leaving the Warehouse are sealed and packed properly and if the vehicle is fit for transporting the products.
• Compile all Quality Inspection Forms prepared by the Sr. Driver & Fleet Coordinator and prepare a monthly report.
• Generate a discrepancy report to the Warehouse Operation, QA & RA Manager for MOH release approval for any late findings (excess, damaged or expired goods) in the shipment.

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.

Admin:

• Develop a professional relationship with the MOH staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations.
• Represent Zahrawi in the MOH and different authorities.
• Negotiate with regulatory authorities for marketing authorization.
• Attend and respond to calls and emails from customers, the Sales team and other support staff.
• Assist the Warehouse Coordinators with relevant documents when requested.
• Coordinate with the Procurement team and assist them with any question they or the Suppliers may have related to MOH importation.
• Keep track of all registration application on Zahrawi’s tracking system.
• Record all active Zahrawi licenses on the Shared folder and ensure they are updated.

REQUIREMENTS

• Education: Bachelors Degree in Pharmacy
• Additional details:
  • Candidates must be based in Oman (Omani national)
  • Candidates must have a valid MOH Pharmacist license.
• Experience: 2+years of experience as applicable – Regulatory Affairs experience in Medical Devices/Pharmaceutical field. Warehouse Pharmacist experience preferred.
• Job Specific Skills: Require a good knowledge in Importation experience through MOH, Environment Portals, HS Codes/ Customs Portal.