Regulatory Affairs Lead

Job description

Regulatory Affairs Lead ABOUT the employer the employer 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 the employer 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 the employer’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 the employer’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, proactively advising internal stakeholders on potential impacts. • Support business development activities, including proposals, reports, costing, and budgets, ensuring alignment with corporate strategy. Governance & Compliance • Ensure all regulatory activities adhere to the employer’s Code of Ethics, corporate policies, and local legislation. • Timely reporting of adverse events, compliance risks, conflicts of interest, and health/environment-related incidents. • Provide regulatory input for audits, inspections, recalls, and related communications to minimize compliance risks. Only applications in KSA will be considered.

Requirements

• Saudi National
• Higher education in pharmaceuticals, medicine, or biotechnology.
• Minimum 9 years’ experience in regulatory affairs (drug development, product approval/launch, line extension, license maintenance, or Health Authority experience), 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.
• Why the employer?
• At the employer we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.
• So, what’s next?
• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.
• Where can I find out more?
• Our Social Media, Follow the employer on LinkedIn
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• the employer 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. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Skills