Are you a strategically focused Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on...
At AstraZeneca work with diverse minds, all united by a shared passion to learn, grow and discover.
Within Oncology Regulatory Science and Strategy (ORSS) 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 work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible.
The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned product(s). You will serve as the global regulatory lead (GRL) on early stage projects or specific indications of larger programs, or as regional regulatory lead. You'll contribute significantly to overall product and clinical strategy. The role plays a key role influencing regulatory authorities through regular contacts to improve regulatory outcomes. The RAD leads cross-functional teams in major regulatory submissions (NDA, IND/CTA), health authority interactions, label discussions, and securing NDA/BLA approvals. As a GRL, the RAD leads the Global Regulatory Strategy Team (GRST) in formulating Global Regulatory strategy and delivering on NDA Filings and Approvals. Alternatively, as a regional regulatory lead, the RAD is a member of the GRST and is accountable for providing the region-specific Regulatory strategy and advice. The RAD serves as the face of the company with health authorities.
Typical Accountabilities, what you will be doing:
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