Regulatory Affairs Executive/specialist

3 weeks ago

Riyadh, Saudi Arabia 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.They are also responsible for the preparation of the pre
- and final permits for the imported items as per the SFDA 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 SFDA.
- 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 SFDA.
- Prepare all required documents to be submitted for Manufacturing Site registration under SFDA.
- Prepare all the Dossiers to be submitted to SFDA for medical, pharmaceuticals and GSL products.
- Prepare and submit samples to SFDA for product registration completion.
- Collect all necessary documents from Supplier to submit for SFDA of products under Ghad System.
- Register reagents with restricted elements through Ghad System.

**Importation Permits**:

- Register and submit the permits through Ghad system.
- 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 weekly / monthly report regarding the rejections/ delays for SFDA importation permits and reasons related to that.
- Check and review the safety data sheet of the restricted element to prepare the required documents for obtaining MOI approval.

**Exportation Permits**:

- Prepare the required documents necessary for obtaining SFDA approval to export medical products outside KSA.

**Importation Rules & Regulations**:

- Communicate with the existing and new suppliers regarding SFDA importation rules and policies.
- Upload on the SFDA 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 SFDA guidelines of imported shipments and take the corrective and preventive action accordingly.
- Review on a regular basis the SFDA importation process of distribution agreements.
- Ensure that the SFDA 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 SFDA regulated or not.
- Coordinate with the Procurement & Logistics Team to update all the required documents in time to avoid importation rejections.

**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**:

- 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 SFDA importation.

**Note: Zahrawi employees must step into other work assigned to them as business needs arise and are not limited to the above.**

***REQUIREMENTS**
- **Education**: Bachelor’s degree (Biology/ Pharmacy/ Biomedical or Science related major is an advantage)
- **Experience**: 2-3 years of relevant experience in regulatory affairs
- **Job Specific Skills**: Effective Communication skills & Good English - Time management skills - Problem Solving Skills - Good computer skills in Ms. Office (Excel
- ERP/Oracle system) - Process Management skills - Detail Oriented - Knowledge about Saber System & Ghad System - Knowledge in SFDA regulations.

Location: KSA - Riyadh

**Job Type**: FULLTIME

Job Posting Date: 17-04-2024

Division/Department: Regulatory Affairs and Pharmacovigilance

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