Are you passionate about transforming science into clear and compelling regulatory documents that drive successful drug development? We are seeking a talented and experienced Associate Director, Clinical Regulatory Writing to join our CVRM (Cardiovascular, Renal and Metabolism) Clinical Regulatory Writing team in Gothenburg, Sweden. With more than 2,400 employees from over 50 countries, our vibrant Gothenburg site is a truly inspiring place to work - where the history and future of scientific breakthroughs come together. We believe that the diversity of our people is crucial to bringing new discoveries to life. Accountabilities: The CVRM Clinical Regulatory Writing group provides expert strategic leadership and communications expertise to clinical drug programs, ensuring delivery of high-quality, label-focused documents aligned with project strategy, regulatory requirements, and communications best practices. Role holders not only author critical clinical-regulatory documents but also act as critical reviewers to achieve the highest quality standards. Team members also represent the Clinical Regulatory Writing skill set on both drug and non-drug projects, advocating for best practices and continuous improvement. Key

Responsibilities

As an Associate Director, Clinical Regulatory Writing, you will: Provide strategic leadership and communication expertise to clinical drug programs across the CVRM portfolio. Author and critically review clinical-regulatory documents, ensuring the highest regulatory, technical, and quality standards. Represent Clinical Regulatory Writing on project teams, advocating for communication best practices. Provide strategic communications leadership within clinical delivery or submission teams, establishing standards and promoting quality and efficiency. Act as NDA/MAA submission lead, driving the development of the clinical Submission Communication Strategy (cSCS) and successful submission delivery. Lead both internal and external authoring teams and cultivate strong partnerships with vendor medical writers to ensure timely, high-quality document delivery. Translate complex clinical data into clear, concise, and accurate messages tailored to specific audiences. Support the development and upskilling of colleagues within the Clinical Regulatory Writing function. Champion continuous improvement and operational excellence in communications. Essential Skills/

Experience

Bachelor's degree in Life Sciences or a related discipline. Significant medical writing experience within the pharmaceutical industry or a Contract Research Organization (CRO). Proven ability to advise and lead communications projects and teams. Strong understanding of drug development and the communications process from early development through to launch and lifecycle management. In-depth knowledge of technical and regulatory requirements relevant to clinical regulatory writing. Desirable Skills/

Experience

Advanced degree in scientific discipline (e.g., Ph.D.). If you are driven to deliver impactful regulatory communications, excel in multidisciplinary teams, and want to shape the future of clinical development, we encourage you to apply. Apply with your CV and cover letter by 30 August! Date Posted 10-aug.-2026 Closing Date 30-aug.-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.