.Location: Barcelona (on-site)Are you a strategically focused Regulatory professional who would like to play an integral part in bringing life changing Oncology medicines to patients? If so, please join us!At AstraZeneca, we work with diverse minds, all united by a shared passion to learn, grow and discover.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 Translational Regulatory Affairs Director (RAD) provides strategic and regulatory leadership to the development, commercialisation, 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 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 late development projects, which meet regulatory agencies' requirements. The Translational RAD 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 Translational RAD plays a key role in working closely with the RADs and other AZ functions assigned to development programs and contributes to product development by facilitating successful regulatory submissions in biomarker-driven programs, including IVDR.In this role, you will be responsible for developing, aligning, and implementing regulatory strategies to ensure successful submissions and approvals with target labels for assigned biomarker-driven development projects on a global scale. The ideal candidate has expertise in IVDR requirements and will be responsible for coordinating IVDR submission activities with internal and external stakeholders. The successful candidate will work closely within cross-functional teams to ensure that regulatory requirements of the biomarker and IVDs in oncology clinical trials, especially innovative biomarkers and technologies (e.G., ctDNA, computational pathology, AI/ML), are met throughout the biomarker 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
