Regulatory Affairs Executive

5 days ago

Manama, Bahrain Zahrawi Medical Full time

**About Zahrawi Group**:
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.

**job Brief**: 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**

**Policies & Procedures**:

- 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.

**Importation Permits**:

- 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.

**Importation Rules & Regulations**:

- 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 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 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.

**Pharmacovigilance**:

- 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 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.

**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

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