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 US 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'll do As Regulatory Affairs Director, you will provide strategic and operational regulatory leadership for assigned development programmes and marketed products. You will serve as a Regional US Regulatory Lead for the Oncology programme. Key responsibilities include: Developing and implementing regional regulatory strategies that support rapid approvals and competitive product labelling. Leading major regulatory submissions, including INDs, NDAs and BLAs. Driving regulatory agency engagement strategies and leading health authority interactions. Leading cross-functional US Oncology Regulatory Strategy teams, clinical development, CMC, labelling and regional regulatory functions. Assessing regulatory risks and developing mitigation strategies to support programme success. Influencing global product strategy through regulatory expertise and scientific insight. Leading preparation of regulatory strategy documents, briefing packages and target labelling. Representing AstraZeneca in discussions with global health authorities and external stakeholders. Essential qualifications Bachelor's degree in Life Sciences, Pharmacy, Biomedical Sciences or a related scientific discipline Significant experience within Regulatory Affairs, Regulatory Strategy and/or drug development in the pharmaceutical or biotechnology industry. Strong experience supporting regulatory strategies across early and late-stage development programmes.

Experience

with regulatory submissions and agency interactions, including INDs, NDAs and/or BLAs. Demonstrated ability to lead complex cross-functional initiatives and influence key stakeholders. Outstanding communication, strategic thinking and problem-solving skills.

Experience

operating effectively in a global matrix environment. Preferred qualifications Oncology regulatory experience. Advanced degree (MS, PharmD, PhD, MD or equivalent).

Experience

leading regulatory strategies through pivotal development milestones and health authority interactions. Prior involvement in regulatory approvals, response teams and labelling negotiations. 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 US market. Compensation and

Benefits

AstraZeneca is committed to providing competitive, equitable and transparent compensation. The annual base pay for this position ranges from $186,232 - $279,349 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).

Benefits

offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 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 14-Aug-2026 Closing Date 27-Aug-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding 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.