AstraZeneca
Executive Director, Global Regulatory Science & Strategy - Oncology
AstraZeneca, Gaithersburg, Maryland, us, 20883
Are you a strategically focused Regulatory professional with global leadership experience that 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.
Define and drive disease area global regulatory priorities and play an essential role in shaping Astra Zeneca’s approach to emerging global oncology initiatives.
Review and/or approve critical documents with regulatory intent, including briefing documents for health authority interactions and high-level documents for global regulatory submissions.
Ensure timely and high-quality marketing applications using existing tools as well as sharing the best submission practices and knowledge.
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.
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.
Varied experience in global regulatory strategy across the phases of drug development, including both early and late drug development.
Significant experience in leading major health authority interactions in major markets.
Broad background of experience working in pharmaceutical/medical industry and prior experience in several areas within regulatory affairs.
Experience in managing people both directly and in a matrixed organizational structure.
Ability to think strategically and critically to evaluate risks to regulatory product development and approval.
Ability to travel domestically and internationally.
Excellent communication and influencing skills.
Preferred:
Advanced degree in a scientific subject area.
Experience working within an alliance.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork.
The annual base salary for this position in the US ranges from $266,093 to $399,140. However, base pay offered may vary depending on multiple individualized factors. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program or to receive a retirement contribution. Benefits offered include a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and health benefits including medical, prescription drug, dental, and vision coverage.
Why AstraZeneca?
At AstraZeneca we’re dedicated to being a phenomenal place to work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development.
So, what’s next!
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
#J-18808-Ljbffr
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.
Define and drive disease area global regulatory priorities and play an essential role in shaping Astra Zeneca’s approach to emerging global oncology initiatives.
Review and/or approve critical documents with regulatory intent, including briefing documents for health authority interactions and high-level documents for global regulatory submissions.
Ensure timely and high-quality marketing applications using existing tools as well as sharing the best submission practices and knowledge.
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.
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.
Varied experience in global regulatory strategy across the phases of drug development, including both early and late drug development.
Significant experience in leading major health authority interactions in major markets.
Broad background of experience working in pharmaceutical/medical industry and prior experience in several areas within regulatory affairs.
Experience in managing people both directly and in a matrixed organizational structure.
Ability to think strategically and critically to evaluate risks to regulatory product development and approval.
Ability to travel domestically and internationally.
Excellent communication and influencing skills.
Preferred:
Advanced degree in a scientific subject area.
Experience working within an alliance.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork.
The annual base salary for this position in the US ranges from $266,093 to $399,140. However, base pay offered may vary depending on multiple individualized factors. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program or to receive a retirement contribution. Benefits offered include a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and health benefits including medical, prescription drug, dental, and vision coverage.
Why AstraZeneca?
At AstraZeneca we’re dedicated to being a phenomenal place to work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development.
So, what’s next!
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
#J-18808-Ljbffr