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.
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, which meet regulatory agencies' requirements.
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 are met throughout the drug development process.
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.
Typical Accountabilities, What You will be Doing
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
Essential
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.
Demonstrated competencies in strategic thinking, internal and external influencing, innovation, initiative, leadership, and exceptional oral and written communication skills.
Strong abilities in communication, negotiation, and problem-solving.
Proficiency in working effectively within cross-functional teams and managing multiple priorities.
Excellent organizational and project management abilities, with keen attention to detail.
Capacity to work autonomously while maintaining high-quality standards.
Desirable
Ability to work strategically within innovative, complex, business critical and high-profile development programs.
Prior experience with Oncology regulatory affairs.
Knowledgeable about regulatory co-development of IVDs/CDx with therapeutic products.
Technical experience and understanding of biomarker innovations such as use of AI/ML computational pathology, or digital health would be advantageous.
Next steps, if the role looks suitable to you, please apply!
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