Regulatory Affairs / Quality Assurance Senior Specialist

The Regulatory Affairs Senior Specialist serves as the liaison between the company and regulatory authorities like SFDA, ensuring imported products including equipment, accessories, and cosmetics are manufactured and distributed in compliance with governmental legislation. This role combines regulatory affairs and quality assurance responsibilities in the pharmaceutical sector. It focuses on product registrations and quality management systems in KSA.

Day-to-day tasks include acting as the main point of contact for SFDA, reporting product status monthly, and following up with logistics for compliant importation. Prepare complete registration dossiers, review documents for SFDA compliance, and coordinate with suppliers on specifications. Track fees, renew licenses timely, and monitor SFDA regulation updates for implementation.

In quality assurance, ensure QMS processes are established, implemented, and maintained while reporting performance to the manager. Apply Good Distribution and Storage Practices and maintain appropriate records. Support internal departments with regulatory requests and complaints.

Join a team handling pharmaceutical imports in Riyadh, collaborating with logistics, suppliers, and authorities. Gain exposure to SFDA platforms like Ghad, NnJzha, and Faseh. Opportunity to stay ahead of regulatory changes impacting company products.