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.
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:
* Prepare and apply for the pre-permit document as per the SFDA guidelines and verify the items being imported and the documents required.
* Apply for the MOH Narcotics and Pre-cursor Chemical permits on the SFDA website as per the specified guidelines.
* 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.
* Additional Details:** Candidate should be Saudi National and based in Riyadh, KSA.
Location: KSA - Riyadh
Job Type: FULLTIME
Job Posting Date: 27-11-2022
Division/Department: Regulatory Affairs and Pharmacovigilance
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