Do you want to shape the future of oncology medicines and influence regulatory decisions that impact patients globally? At AstraZeneca, we are driven by our commitment to advancing science and delivering life-changing medicines. As a Regulatory Affairs Director, you will play a pivotal role in defining and executing EU regulatory strategies that accelerate innovation and bring transformative oncology therapies to patients worldwide. This is an opportunity to lead complex regulatory initiatives across development, submission, approval and lifecycle management activities while partnering with leading scientists, clinicians and commercial teams across a global matrix environment. Why AstraZeneca? At AstraZeneca, we follow the science and put patients first. You will join a culture that values curiosity, courage and collaboration, where talented individuals are empowered to challenge convention and shape the future of healthcare. We invest in our people through meaningful career development, global mobility opportunities, leadership programmes and cutting-edge scientific innovation. Our Oncology business continues to redefine what is possible in cancer treatment, creating opportunities for regulatory leaders to influence some of the most exciting programmes in the industry. What you will do? Lead cross functional teams in major regulatory submissions (MAA/CTR/IVDR/CTA), health authority interactions with EMA or national European health authorities, label discussions, and securing approvals. Develop and implement the program's regional or global strategy ensuring that it is crafted to deliver rapid approval with competitive labeling that is identified by the business, markets and patients. Craft the EU health authority engagement strategy and interaction plan, drive the formulation of the briefing document focused on strategy and scientific content, lead the team through meeting rehearsals and moderate the meeting itself. Key contribuiting members to the Global Regulatory Strategy Team (GRST) that includes regions, emerging markets, RA CMC, Labeling and members of the submission and execution team. Mentor and provide performance feedback to members of your GRST. Deliver regulatory milestones on your team including an assessment of risks and mitigations, emerging data, and the probability of success. Lead preparation of the regulatory strategy document and target product labeling in collaboration with the GRL. Own the negotiations with health authorities and initiate and deliver key regulatory documents. Plan and construct the global dossier and core prescribing information including product maintenance, supply and compliance activities. Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance. Minimum Qualifications: Bachelor's degree in Life Sciences, Pharmacy, Biomedical Sciences or a related scientific discipline with a + 5 years’ experience in regulatory affairs, regulatory strategy, or drug development within the pharmaceutical or biotechnology industry; including preparation for major health authority interactions, development of briefing documents, contribution to labeling strategy, and support for regulatory submission planning and execution. Experience with filing of IVDR, CTR, CTAs, MAAs, lifecycle management activities, and regulatory pathways (relevant to oncology products is preferred) Strong knowledge of global regulatory affairs across  both early and late-stage development, with experience supporting or shaping regulatory strategies for major submissions and health authority, primarily In Europe. Outstanding communication, strategic thinking and problem-solving skills. Experience operating effectively in a global matrix environment, lead through complexity, and drive alignment across multiple functions is essential. Preferred Qualifications: Advanced degree preferred. Experience in Oncology is preferred. Prior experience with phase 3 design including end of phase 2 health authority interactions. Contribution to a regulatory approval including leading response team and labeling negotiations. Knowledge and understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design. Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Ability to work strategically within a business critical and high-profile development program. Critical thinking on current global and regional regulatory science questions and good understanding of the corresponding scientific and clinical component. What success looks like In this role, you will: Deliver critical regulatory milestones for Oncology that support programme progression and approvals. Build productive relationships with health authorities and key internal stakeholders. Provide strategic leadership across complex, high-profile development programmes. Influence decisions that drive patient access to innovative medicines in the EU market. Inclusion & Diversity AstraZeneca is an equal opportunity employer committed to fostering an inclusive and diverse workplace. We welcome applications from all qualified candidates and make employment decisions without regard to legally protected characteristics. Ready to make an impact? Join AstraZeneca and help deliver the next generation of medicines that transform the lives of patients around the world. Apply today to become part of a team where science, innovation and collaboration drive meaningful change. Date Posted 22-Oct-2026 Closing Date 04-Nov-2026 Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. 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.

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