Regulatory Affairs Lead

Regulatory Affairs Lead ABOUT ASTRAZENECA AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. SITE DESCRIPTION   AstraZeneca is experiencing a significant transformation in the Kingdom of Saudi Arabia, driven by a commitment to advancing healthcare, innovation, and sustainable growth. Building on our global legacy, AZ KSA is rapidly evolving its operations to better serve patients, collaborate with healthcare stakeholders, and contribute to the ambitious goals outlined in the Saudi Vision 2030. We are investing in talent, digital solutions, and new ways of working; all designed to enhance our impact on patient outcomes and reinforce our leadership in therapeutic areas. This dynamic environment calls for visionary, agile professionals who thrive in change and are motivated to help shape the future of healthcare in KSA.  ROLE SUMMARY The Regulatory Affairs Lead is responsible for driving regulatory strategies and managing submissions across the product lifecycle to ensure compliance with local and global requirements. The role provides expert advice on processes and documentation, proactively manages regulatory risks, and partners with health authorities and internal stakeholders to enable timely patient access to innovative medicines. The role reports to the Regulatory Affairs & Pricing Director and supports the RA agenda through the established RA governance. What you’ll do Regulatory Strategy & Submissions • 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 (e.g., SFDA, GHC) and ensure timely updates to global systems on regulatory guidelines, decrees, and communications. • Business Partnering & Country RA Agenda • Partner with Business Units and relevant internal stakeholders to support the country regulatory agenda, under the leadership of the Regulatory Affairs & Pricing Director. • Conduct regular meetings with local agents’ regulatory teams to align on outstanding activities and ensure smooth execution. • Foster alignment across therapy area RA managers, local agents, and global stakeholders on regulatory priorities. • Represent AstraZeneca’s regulatory interests in official engagements with authorities and industry forums. Leadership & People Development • Manage and develop a small team of regulatory professionals (1–2 direct reports), setting clear objectives, coaching, and providing growth opportunities. • Promote a culture of collaboration, creativity, and courageous leadership across teams. • Lead or participate in critical projects, ensuring regulatory business needs are integrated into AZ’s systems, processes, and standards. External Engagement & Business Awareness • Build and maintain strong relationships with Regulatory Health Authorities, industry representatives, and key external partners. • Monitor regulatory, policy, and industry dynamics, proacti