.Are you a strategically focused Regulatory professional with global leadership experience who would like to play an integral part in bringing life-changing oncology medicines to patients? If you are, please read on...AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that discovers, develops, and commercializes ground-breaking medicines for some of the world's most serious diseases. We explore innovations and confront challenges that others won't, to have a greater impact on patient lives. Working on a strong pipeline means much more than producing innovative, ground-breaking medicines. Our vision is to change the face of our industry for good and to redefine the careers of our people.We're committed to a culture of continuous learning and people development so everyone at AstraZeneca can grow and thrive. The Executive Director, Regulatory Science & Strategy provides global strategic regulatory expertise and oversight to support the research, development, and commercialization of products across both small molecules and biologics within the Oncology Regulatory Science and Strategy (ORSS) group. This role will involve oversight of fast-paced, innovative projects. More specifically, the position will:Provide critical review and input on multiple oncology disease area and portfolio regulatory strategies, risk planning, and mitigations. The strategies should be crafted and negotiated with global health authorities to deliver a rapid approval with competitive labelling in keeping with the properties of the product(s) and the needs identified by the business and patients.Define and drive disease area global regulatory priorities and play an essential role in shaping AstraZeneca's approach to emerging global oncology initiatives.Review and/or approve critical documents with regulatory intent, including briefing documents for health authority interactions, high-level documents for global regulatory submissions, as well as core prescribing information.Effectively represent the Global Regulatory Affairs function in senior-level interactions at internal governance technical review committees, key global health authority meetings, and with external partners.Lead, develop, and coach Regulatory Affairs Directors (US and EU regional regulatory leads) and Senior Directors (global regulatory leads), as well as recruit new staff. Foster an open and transparent environment that maximizes the potential of staff.Collaborate with regional policy and intelligence groups to critically analyze emerging science, data, and changes in the regulatory environment and advise senior management on project risks and mitigations activities accordingly.Minimum Qualifications:Bachelor's degree in life sciences or related field.A minimum of 10 years of proven experience in strategic drug development.Deep oncology therapy area knowledge, including understanding of scientific, medical, and regulatory environments
