General Manager Regulatory Affairs Genedrift APAC Pte Ltd

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