Regulatory Affairs Specialist

About the Role
Support the registration, maintenance, and compliance of pharmaceutical products with the SFDA and regional health authorities—driving timely submissions, approvals, and adherence to all regulatory requirements.

Key Responsibilities

• Manage product registrations, renewals, variations, and pricing submissions to SFDA and GCC authorities.
• Serve as the primary liaison with SFDA for Scientific Office and Regulatory Affairs communications, including handling and closing authority queries.
• Oversee market maintenance obligations, such as shortage notifications and related compliance requirements.
• Ensure compliance of both promotional and non-promotional activities (materials, events, digital content) with SFDA regulations.
• Coordinate with QA, Medical, Marketing, and Supply Chain teams to collect documentation, support submissions, and maintain accurate records and archives.
• Monitor regulatory updates and translate them into practical internal actions (e.g., SOPs, templates, brief trainings).

Qualifications

• BSc Pharmacy / PharmD
• 1–3 years of Regulatory Affairs experience in the Saudi market; export market exposure is a plus.
• Familiarity with Scientific Office obligations and SFDA e-services; working knowledge of eCTD/RIM is an advantage.
• Strong organization, attention to detail, and stakeholder communication (Arabic & English).

Regards,