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,
