Associate Director Of Translational Regulatory Science

hace 1 mes

Barcelona, España Astrazeneca A tiempo completo

.Associate Director of Translational Regulatory Science Within Oncology Regulatory Science, Strategy & Excellence (ORSSE), we bring hope and solutions to patients 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 work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. The Associate Director of Translational Regulatory Science provides strategic and regulatory leadership to the development, commercialization, and life cycle management of assigned product(s) with a specific focus on translational areas. Translational areas are development opportunities that take place in cross-functional teams and focus on biomarkers or approaches such as the development of novel therapeutics, endpoints, in vitro diagnostics (IVDs), regulatory innovations, or the introduction of digital therapeutics in development programs. This requires early anticipation of the potential regulatory impact and developing capabilities to design regulatory strategies applicable to early and late development projects, which meet regulatory agencies' requirements. The Associate Director of Translational Regulatory Science interfaces between the functional areas involved in these projects, participates in the projects as a team member, and helps identify all necessary regulatory aspects that may benefit from interactions with regulatory authorities in both early and late stages of development or through an ongoing development program. The Associate Director of Translational Regulatory Science plays a key role in working closely with the Regulatory Affairs Directors (RADs) assigned to development programs and contributes to product development by organizing regulatory authority interactions dedicated to focused topics to be an integral part of a development program. In this role, you will be responsible for developing, aligning, and implementing regulatory strategies to ensure successful early and late Oncology development projects on a global scale. The successful candidate will work closely within cross-functional teams to ensure that regulatory requirements in Oncology clinical trials, including those for innovative biomarkers, technologies (e.G., ctDNA, computational pathology, AI/ML), and therapeutics are met throughout the drug development process. The impact and visibility of this position are high, with implications for regulatory decisions, timelines, and advancement for the company in contributing to the ORSSE "Roadmap" implementation. If you are a Regulatory professional with a passion for Oncology and want to make a difference in the lives of cancer patients, please apply to join our team at AstraZeneca

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