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.Role Overview: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. This role requires early anticipation of the potential regulatory impact and developing capabilities to design regulatory strategies applicable to early and late development projects that meet regulatory agencies' requirements.Key Responsibilities:Guide the development of global regulatory strategies to facilitate the advancement of early and late Oncology programs.Develop and implement regulatory strategies to support the clinical development of Oncology therapeutic products.Work closely within cross-functional teams, actively participating in decision-making processes related to drug development queries.Serve as a Regulatory Affairs representative on designated global project teams, offering strategic insights and guidance.Engage with major health authorities to optimize regulatory strategies and maintain productive relationships.Organize preparations for meetings and teleconferences with local and global health authority officials.Keep abreast of relevant regulatory policies and guidelines.Drive opportunities for external engagement, contributing to relevant publications and participating in external speaking events.Education, Qualifications, Skills, and Experience:Advanced degree in life sciences or a related field, such as Ph.D., Pharm.D., or M.Sc.Minimum of 2 years of experience in regulatory affairs or a closely related field.Expertise in therapeutic product regulations, with a thorough understanding of global regulatory frameworks.Understanding of regulatory affairs in Oncology throughout both early and late-stage development.#J-18808-Ljbffr
