Cmc Regulatory Affairs Associate Director Biologics |

hace 2 meses


Barcelona, España Astrazeneca A tiempo completo

CMC Regulatory Affairs Associate Director BiologicsLocation - BarcelonaCompetitive salary and benefits packageIntroduction 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?AccountabilitiesAs 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.Providing strategic, tactical, and operational expertise and direction to AstraZeneca project teams.Handling high-level risk and supporting project-driven regulatory interactions with health authorities.Leading and/or delivering CMC Regulatory components of business process improvement projects.Sharing 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 science.Significant 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 authority.Project and process management skills.Desirable Skills/Experience:Advanced degree or equivalent experience in a science or technical field such as pharmacy, biology, chemistry, or biological science.Regulatory experience across global projects and several regions for antibody drug conjugates, radioconjugates, or bispecifics.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.#J-18808-Ljbffr



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