General Manager Regulatory Affairs

Job Description

Lead and manage the licensed SFDA consulting establishment in Saudi Arabia, with primary responsibility for consulting services related to Drugs and Medical Devices, ensuring full compliance with SFDA regulations, guidelines, and licensing conditions for consulting establishments.

Core Responsibilities:
– Serve as full‑time General Manager / Director of the SFDA‑licensed consulting establishment in KSA, accountable for overall compliance with SFDA requirements for consulting services establishments
– Oversee consulting services for Drugs and Medical Devices.
– Establish, implement, and maintain internal quality procedures and a quality policy governing how technical reports, submissions, and opinions are prepared, reviewed, approved, archived, and communicated to clients
– Develop and maintain the organizational structure and approved list of technical and administrative staff.
– Act as primary contact with SFDA for licensing, inspections, audits, and any follow‑up actions
– Monitor SFDA regulations, guidelines, circulars, and updates related to Drugs and Medical Devices
– Ensure independence, impartiality, and avoidance of conflicts of interest across all consulting engagements
– Protect confidentiality of all client and product information during and after the validity of the license

Additional Responsibilities
Support strategic expansion of licensed activities (e.g., Pharmacovigilance, Cosmetics, Food) in coordination with SFDA, ensuring that all new activities are staffed and managed per SFDA standards before license update requests

Desired Candidate Profile

Saudi Arabian

Bachelor of Pharmacy

Any

Essential Profile: – Saudi national, full‑time, holding at least a Bachelor’s degree in Pharmacy or Pharmaceutical Sciences. Optional are Biomedical Engineering, Medical Devices, or a closely related discipline relevant to SFDA‑regulated products – Minimum 2–4 years’ experience in regulatory affairs or consulting for Drugs and/or Medical Devices, with direct exposure to SFDA processes (or other Health Authorities plus strong willingness to specialize in SFDA) – Demonstrated knowledge of SFDA regulations related to pharmaceutical establishments and medical devices, and familiarity with the SFDA consulting establishments guide – Experience in managing technical teams is preferred and ability to develop SOPs/quality systems, and handling Health Authority communications and inspections – High level of integrity, independence, and client‑service orientation consistent with SFDA expectations for consulting establishments