Regulatory Affairs Executive

Zahrawi Group is a leading company in the GCC Healthcare Industry with its presence in UAE, KSA, Qatar, Bahrain, & Oman markets. The company supplies and distributes high-quality products and services to Hospitals, Clinics, Laboratories, & Analytical Industries.

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.

ACCOUNTABILITIES

Adhere to all Zahrawi Policies & Procedures as applicable.

Regulatory Affairs:

Ensure that Zahrawi's products comply with the regulations of the NHRA.

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.

• Prepare and apply for the permit document as per the NHRA guidelines and verify the items being imported and the documents required.
• Apply for the NHRA regulated products permits on the NHRA website as per the specified guidelines.
• Register and submit the permits for SCE when required.
• 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 NHRA importation permits and reasons related to that.
• Communicate with the existing and new suppliers regarding NHRA importation rules and policies.
• Upload on the NHRA importation system any new classifications or registration certificates.
• Ensure that all urgent requests 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 NHRA guidelines of imported shipments and take the corrective and preventive action accordingly.
• Review on a regular basis the NHRA importation process of distribution agreements.
• Ensure that the NHRA 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 NHRA regulated or not.
• Coordinate with the Procurement & Logistics Team to update all the required documents in time to avoid importation rejections.
• Act as the LRPPV (Local Responsible Person for Pharmacovigilance).
• Perform regulatory intelligence by screening the NHRA 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.
• Responsible for all Pharmacovigilance related work and assigned as the LRPPV (Local Responsible Person for Pharmacovigilance).
• 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 preparing 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 communicate 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.

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 NHRA.

Prepare all required documents to be submitted for Manufacturing Site registration under NHRA.

Prepare all the Dossiers to be submitted to NHRA for product registration.

Collect all necessary documents from Supplier to submit for 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 NHRA 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 NHRA 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 NHRA staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations.
• Represent Zahrawi in NHRA 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 NHRA 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.

• Education: Bachelors Degree in Pharmacy
• Candidates must be based in Bahrain.
• Bahraini national is preferred.
• Candidates must have a valid Pharmacist license.
• RAO license is a plus.
• Experience: Fresh graduates or 1+ years of relevant experience in regulatory affairs within Bahrain is preferred.
• Job Specific Skills: Excellent Interpersonal Skills & Good English – Good computer skills in Ms. Office (Excel– ERP/Oracle system) - Knowledge about Regulatory Affairs, Product Classification and Importation Regulations as per NHRA.