Regulatory Affairs Lead

Job Title : Regulatory Affairs Lead 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. 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. 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 and ensure timely updates to global systems on regulatory guidelines, decrees, and communications. Requirements : Saudi National Higher education in pharmaceuticals, medicine, or biotechnology. Minimum 9 years’ experience in regulatory affairs, including at least 5 years 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 teamworking skills across global functions. Proven people management capabilities. Strong business acumen, including financial and strategic awareness. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.

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