Regulatory Affairs Lead at AstraZeneca

Riyadh, Riyadh Region, Saudi Arabia -

Full Time

Start Date

Immediate

Expiry Date

03 Jan, 26

Salary

0.0

Posted On

05 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Submission Management, Regulatory Expertise, Risk Management, Product Licensing, Safety Reporting, Team Management, Collaboration, Business Acumen, Compliance, Health Authority Engagement, Project Management, Communication, Leadership, Industry Knowledge, Stakeholder Management

Industry

Pharmaceutical Manufacturing

Description

JOB TITLE 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. 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. 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 Serve as the regulatory contact for the Country Head and Business Unit Directors (BUDs). 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, 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 AstraZeneca’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. Essential for the role 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 AstraZeneca? At AstraZeneca 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 AstraZeneca on LinkedIn Follow AstraZeneca on Facebook Follow AstraZeneca on Instagram Date Posted 05-أكتوبر-2025 Closing Date 11-أكتوبر-2025 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. 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

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. This role involves providing expert advice, managing regulatory risks, and partnering with health authorities to enable timely patient access to innovative medicines.