Regulatory Affairs Lead📣 إعلان

About AstraZeneca

AstraZeneca is a global biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines for serious diseases. AstraZeneca in the Kingdom of Saudi Arabia is undergoing a significant transformation to advance healthcare, innovation, and sustainable growth, aligning with Saudi Vision 2030. The company is investing in talent, digital solutions, and new ways of working to enhance patient outcomes and reinforce leadership in therapeutic areas.

The Role of Regulatory Affairs Lead

The Regulatory Affairs Lead is responsible for developing regulatory strategies and managing submissions throughout the product lifecycle to ensure compliance with local and global requirements. This full-time position is based in Riyadh, Saudi Arabia, and reports to the Regulatory Affairs & Pricing Director. The role provides expert advice on processes and documentation, proactively manages regulatory risks, and collaborates with health authorities and internal stakeholders to facilitate timely patient access to innovative medicines.

Key Responsibilities

• Lead submission management and cross-functional teams for complex global regulatory applications, ensuring compliance with AstraZeneca’s submission-ready standards.
• Provide regulatory expertise and strategic input to product and project teams, anticipating Health Authority requirements and guiding submissions-related activities.
• Identify potential regulatory risks to global and regional operational plans, proposing mitigation strategies.
• Implement and oversee strategies that improve the quality, efficiency, and timeliness of submissions.
• Manage processes related to product licenses, registrations, and post-marketing requirements, including labeling, safety reporting, inspections, and audits.
• Act as the primary regulatory contact with key authorities (*, SFDA, GHC) and ensure timely updates to global systems on regulatory guidelines, decrees, and communications.
• Partner with Business Units and relevant internal stakeholders to support the country regulatory agenda.
• Conduct regular meetings with local agents’ regulatory teams to align on outstanding activities and ensure smooth execution.
• Manage and develop a small team of regulatory professionals (1–2 direct reports), setting clear objectives, coaching, and providing growth opportunities.
• Build and maintain strong relationships with Regulatory Health Authorities, industry representatives, and key external partners.
• Monitor regulatory, policy, and industry dynamics, proactively advising internal stakeholders on potential impacts.
• Ensure all regulatory activities adhere to AstraZeneca’s Code of Ethics, corporate policies, and local legislation.

Qualifications and Experience

• Saudi National.
• Higher education in pharmaceuticals, medicine, or biotechnology.
• Minimum of 9 years of experience in regulatory affairs, including drug development, product approval/launch, line extension, license maintenance, or Health Authority experience.
• At least 5 years of experience in a multinational environment with proven contributions.
• Strong knowledge of local and international regulatory standards, requirements, and industry practices.
• Demonstrated ability to manage pivotal projects and resource requirements.
• Excellent collaboration and teamwork skills across global functions.
• Proven people management capabilities.
• Strong business acumen, including financial and strategic awareness.

Application Information

This role offers an opportunity to contribute to AstraZeneca's mission in advancing healthcare within Saudi Arabia. The salary for this position will be disclosed during the recruitment process.