.CMC Regulatory Affairs Associate Director Biologics Location - Barcelona Competitive salary and benefits package Introduction to roleJoin our dynamic team at AstraZeneca as a CMC Regulatory Affairs Associate Director. Based in our Barcelona, Spain hub, you will be a core member of our cross-functional Regulatory Strategy, Biopharmaceutical and Global Supply Teams. This role is an opportunity to support the biologics technical area, encompassing both traditional and novel molecules. We pride ourselves on our encouraging culture and cross-project knowledge sharing. Are you ready to unlock knowledge and learning opportunities with us? Accountabilities As a CMC Regulatory Affairs Associate Director, your responsibilities will include devising creative strategies to support a range of new biologics and novel products, from development to post approval lifecycle management. You will provide strategic, tactical and operational expertise and direction to AstraZeneca project teams, handle high level risk, support project driven regulatory interactions with health authorities, lead and/or deliver CMC Regulatory components of business process improvement projects, and share your knowledge actively within CMC RA and the wider business. Essential Skills/Experience:Bachelor's degree or equivalent experience in a science or technical field such as pharmacy, biology, chemistry or biological scienceSignificant experience of working in one or more areas in regulatory affairs in the biopharmaceutical industry, or in regulatory drug development, product approval/launch, line extension and license maintenance, or experience at a health authorityProject and process management skills Desirable Skills/ExperienceAdvanced degree or equivalent experience in a science or technical field such as pharmacy, biology, chemistry or biological scienceRegulatory experience across global projects and several regions for antibody drug conjugates, radioconjugates or bispecificsWhen 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.At AstraZeneca, we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We are all compassionate team players and driven achievers, always ready to step up. We're motivated by science, success and achieving our goals in a way that's novel and thoughtful
