Início Arábia Saudita Regulatory Affairs Executive/Specialist

Início Arábia Saudita Regulatory Affairs Executive/Specialist

Regulatory Affairs Executive/Specialist

Full time na Al Zahrawi Medical Supplies LLC no Saudi Arabia
Publicado em April 27, 2024

Detalhes do emprego

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:
  • 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.
Skills
  • 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 – Knowledgeabout Saber System & Ghad System - Knowledge in SFDA regulations.
  • Additional Details: Candidate should be a Saudi National and based in Riyadh, KSA.
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