International CMC Regulatory Affairs Manager I

Job Title: International CMC Regulatory Affairs Manager I Global Career Level: D1 Introduction to role This role manages the end-to-end delivery of Chemistry, Manufacturing and Control (CMC) documentation for assigned product ranges, ensuring regulatory submissions meet business needs and patient expectations across the full product lifecycle. It involves leading and coordinating international CMC regulatory submissions, so that activities, data and documentation are delivered to the right quality, on time and in line with global requirements. The role leads and contributes to the CMC regulatory components of key business projects, maintaining strong communication with stakeholders and project teams so that timelines, risks and regulatory commitments are clearly understood. It also ensures international CMC regulations and guidance are applied consistently, while helping to shape new internal guidance, policy and processes that raise standards and improve ways of working. Accountabilities Lead the planning, preparation, authoring and delivery of CMC content for marketing authorisation applications and post-approval submissions, ensuring high-quality, compliant dossiers. Coordinate and project manage international CMC submission activities, tracking progress, managing risks and adapting plans to meet changing priorities and regulatory expectations. Maintain clear documentation of Health Authority approval status and commitments, ensuring information is accurate, current and accessible to relevant stakeholders. Build and deepen expertise in regional regulatory requirements to secure compliance of CMC submissions and anticipate regulatory trends. Share learnings from projects across teams to strengthen collective regulatory knowledge and improve future submissions. Support the use of fit-for-purpose content by applying regulatory intelligence to optimise submission strategies and outcomes. Participate in regulatory execution and delivery meetings, providing concise updates and insight to the CMC team. Contribute to business process optimisation initiatives that reduce waste, streamline workflows and enhance efficiency. Continuously develop regulatory expertise through proactive recording and communication of Health Authority interactions, responses and commitments. Apply appropriate GxP principles according to product lifecycle stage, ensuring robust quality and compliance. Take responsibility for assigned change management activities, assessing impact and ensuring changes are implemented in a controlled way. Apply risk management principles across activities to identify, assess and mitigate potential issues. Demonstrate strong research skills in interpreting regulations and guidance from multiple agencies, translating them into practical CMC strategies. Operate in line with AstraZeneca Values, Code of Ethics and all relevant policies and standards, completing required training on time and reporting potential non-compliance. Follow standard processes, actively identify and solve problems, and define and implement improvements that drive continuous enhancement of regulatory performance. Essential Skills/Experience University degree in a science or technical field such as pharmacy, biology, chemistry or biological science. Minimum 7 years of Relevant experience from biopharmaceutical industry, or other relevant experience Breadth of knowledge of manufacturing, project, technical and regulatory management. IT Skills Stakeholder & Project management Professional capabilities: Regulatory knowledge Desirable Skills/Experience Knowledge of the drug development process and regulatory submissions Understanding of current regulatory CMC requirements Direct/indirect Regulatory Affairs CMC experience with submissions for medicinal products Understanding of regulations and guidance governing the manufacture of medicinal products Lean capabilities When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. AstraZeneca offers the chance to work on meaningful science that directly shapes how life-changing medicines reach patients worldwide, with a rich pipeline that spans the full drug development journey. Regulatory professionals collaborate across locations, therapy areas and external partners to solve complex problems, use data and analytics to shorten development cycles, and pioneer modern regulatory approaches for niche patient populations. It is an inclusive environment where diverse perspectives are valued, people are trusted with real responsibility, encouraged to ask questions, try new ideas and act as agents of change, while benefiting from global opportunities to grow skills, explore different roles and build a long-term career. Ready to step up, drive impactful CMC submissions and help bring transformative medicines to patients faster? Apply now. Date Posted 25-May-2026 Closing Date 05-Jun-2026 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. 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.