General Manager Regulatory Affairs

Job Description

Lead and oversee an SFDA-licensed consulting establishment in Saudi Arabia, with full accountability for consulting services related to Drugs and Medical Devices, ensuring strict adherence to SFDA regulations, guidelines, and licensing requirements.

Key Responsibilities

• Act as the full-time General Manager / Director of the SFDA-licensed consulting entity in KSA, ensuring continuous compliance with all SFDA requirements applicable to consulting establishments
• Supervise and deliver consulting services related to Drugs and Medical Devices in accordance with SFDA standards
• Develop, implement, and maintain a robust quality management framework, including internal procedures governing preparation, review, approval, archiving, and communication of technical reports, submissions, and regulatory opinions
• Establish and maintain an approved organizational structure, including qualified technical and administrative personnel
• Serve as the primary liaison with SFDA for licensing matters, inspections, audits, and regulatory follow-ups
• Track and interpret SFDA regulations, guidelines, circulars, and updates related to Drugs and Medical Devices
• Ensure independence, impartiality, and conflict-of-interest controls across all consulting activities
• Safeguard the confidentiality of client and product information during and after the validity of the SFDA license

Additional Responsibilities

• Support the strategic expansion of licensed activities (e.g., Pharmacovigilance, Cosmetics, Food) in coordination with SFDA
• Ensure all new activities are appropriately staffed, structured, and compliant with SFDA standards prior to submitting license amendment requests

Desired Candidate Profile

Essential Requirements

• Saudi national, available full-time, with a Bachelor’s degree in Pharmacy or Pharmaceutical Sciences
  (Biomedical Engineering, Medical Devices, or closely related SFDA-relevant disciplines are an advantage)
• 2–4 years of experience in regulatory affairs or consulting for Drugs and/or Medical Devices, with hands-on exposure to SFDA processes
  (Experience with other Health Authorities is acceptable with strong commitment to SFDA specialization)
• Strong understanding of SFDA regulations governing pharmaceutical establishments, medical devices, and consulting establishments
• Experience in team leadership, development of SOPs and quality systems, and managing Health Authority communications and inspections
• Demonstrated integrity, independence, and client-focused professionalism aligned with SFDA expectations for licensed consulting establishments
  
  

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