Director, Clinical Regulatory Writing

Are you ready to translate groundbreaking science into strategic regulatory messaging that drives successful submissions and approvals? We’re hiring a Director, Clinical Regulatory Writing, to lead communications strategy and delivery for our Cardiovascular, Renal and Metabolism (CVRM) portfolio. As the Director of Clinical Regulatory Writing, you'll be at the forefront of driving strategic communication excellence to achieve successful submissions and approvals. Our team provides expert communications leadership to drug projects, crafting clinical-regulatory documents that align with project strategies and regulatory requirements. You'll be engaged in multiple high-priority programs, acting as both a leader and coach, advocating for the team and fostering an environment of productivity and engagement. Your role will involve developing communication strategies, optimize document delivery, and supporting talent growth within CVRM across all phases of clinical development. You will be a visible champion for best practice, innovation, and continuous improvement across the therapy area. This role is based at AstraZeneca’s dynamic R&D site in Gothenburg, where you will join an international, collaborative and cross‑functional environment. Accountability Provide expert leadership across a group of submissions or programs, overseeing the communication strategy. Lead submission activities and author documents within a program. Review key submission documents for consistency of messaging. Influence stakeholders at the highest levels of the organization to establish best communications practices. Represent Clinical Regulatory Writing on various improvement workstreams and external activities. Drive resourcing strategy within area of accountability. Support recruitment and onboarding activities for new members of the group. Develop and embed innovative best practices, tools, and processes that elevate quality, speed, and impact. Support talent growth through mentoring and coaching, acting as a role model for the function. Essential skills/experience Bachelor’s degree in Life Sciences or related discipline, PhD is strongly preferred. Significant experience in medical/regulatory writing within pharmaceutical/biotech or CRO environments. Proven ability to advise on and lead complex communication programs and submission teams. Strong understanding of drug development and the end‑to‑end communications process from early development through launch and lifecycle management. In‑depth knowledge of relevant technical and regulatory requirements; track record of delivering high‑quality, label‑focused documents under tight timelines. Desirable skills/experience Advanced scientific degree (e.g., PhD). Experience in using AI tools for medical writing You’ll influence pivotal regulatory outcomes for programs that address some of the world’s most prevalent diseases. You’ll lead at scale, shape standards, and grow future leaders, while collaborating with world‑class cross‑functional teams committed to scientific excellence and patient impact. Ready to lead communications that make a difference? Apply by April 29th, 2026. Date Posted 08-apr.-2026 Closing Date 29-apr.-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.