Regulatory Affairs Executive/Specialist
- الرياض
- دائم
- دوام كامل
- Adhere to all Zahrawi Policies & Procedures as applicable.
- 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.
- 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.
- 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.
- Prepare the required documents necessary for obtaining SFDA approval to export medical products outside KSA.
- 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.
- 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.
- 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.