Do you want to play a pivotal role in channeling our scientific capabilities and make a positive impact on changing the lives of patients? Join us as our Senior Director CMC Thechnical Authoring in Global Technical Operations! In Operations, we have a big ambition – to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking. Global Biologic Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast-paced, challenging and rewarding work environments in the world of operations and biopharmaceutical manufacturing. Your opportunity to make a difference We can now offer an exciting opportunity to join Global Technical Operations (GTO) as our Senior Director CMC Technical Authoring. The role is based at our manufacturing site in Södertälje, Sweden. You will report to Vice President, Global Technical Operations What you will do As Senior Director CMC Technical Authoring, you will hold a strategic leadership role covering Biologics commercial products. Working closely with Biopharmaceutical Development, Pharmaceutical Technology & Development, Manufacturing, Supply, Quality and CMC Regulatory Affairs, you will provide regulatory leadership across GTO and our partners. Alongside regulatory strategy and lifecycle management, you will be accountable for enabling our future-state digital regulatory capability, including AI-enabled authoring, structured content management, regulatory knowledge management and automated post-approval submission processes. Your primary responsibility will be to lead the authoring of post-approval regulatory submissions for Biologics. Digital & AI Submissions Transformation You will help shape and drive the future of AI-enabled regulatory operations, leading the transformation of post-approval submissions through generative AI, automation and structured content management. In close partnership with Digital, Data & AI, IT, Quality and Regulatory Affairs, you will drive the development of connected regulatory knowledge, intelligent authoring solutions and reusable content that improve speed, consistency and quality across the submission lifecycle. You will also establish robust governance and GxP-compliant approaches for AI-enabled solutions, define measures of impact and adoption, and lead the organisational change and capability building required to embed new ways of working. With a strong external perspective, you will help position GTO at the forefront of AI-enabled regulatory strategy and advance the long-term ambition of increasingly autonomous preparation of routine post-approval submissions. Key Responsibilities Create and execute a 3–5 year roadmap enabling independent authoring of post-approval submissions using AI, automation, and structured content management. Implement generative AI solutions for drafting, summarization, impact assessments, comparability narratives, health authority responses, and lifecycle management documentation. Partner with Digital, Data & AI, IT, Quality, and Regulatory Affairs organizations to deploy regulatory copilots and document intelligence solutions. Lead organizational change management, training, and capability-building for digital and AI-enabled regulatory operations. Benchmark external industry practices and position GTO as a leader in AI-enabled regulatory strategy and lifecycle management. Essential Requirements Bachelor’s or Master’s Degree in Life Science or related discipline Extensive experience in regulatory affairs, including leading regulatory or cross-functional teams and direct interaction with health authorities Proven expertise in navigating international regulatory environments and driving regulatory strategy, project delivery, and compliance for pharmaceutical products Demonstrated leadership, strategic thinking, and the ability to evaluate risks and business impacts in ambiguous, complex settings Highly developed written, verbal, and interpersonal communication skills with experience influencing key decisions and building effective partnerships Strong program management skills and experience in resource planning and operational oversight Desirable Experience/Knowledge Advanced degree (PhD, PharmD) or further professional qualifications Experience across multiple therapeutic areas or within regulatory operations, drug project delivery, or compliance in a global context Knowledge of evolving global and regional regulations and best practices Are you already imagining yourself in this role? Good, because we can´t wait to hear from you! Why AstraZeneca At AstraZeneca, you will be part of a community united by one purpose: delivering medicines to patients quickly, reliably and sustainably. Your experience and leadership will be valued as you bring people, processes and partners together to strengthen our global supply network. Here, you will have the space to share your ideas, grow alongside skilled colleagues and make an impact that reaches far beyond your immediate team. What’s next If this sounds like the kind of challenge where you could bring your strengths and continue to grow, we would love to hear from you. Join us in leading a dedicated team, shaping the future, and helping medicines reach the patients who need them. We look forward to getting to know you. Please submit your application by no later than November 17, 2026. Date Posted 03-nov.-2026 Closing Date 17-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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