Executive Director, Global Regulatory Science & Strategy - Oncology

Company: National Black MBA Association
Location: Boston
Posted on: November 13, 2024

Job Description:

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. 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 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, high-level documents for global regulatory submissions as well as core prescribing information.
• 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. 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.
  • Varied experience in global regulatory strategy across the phases of drug development, including both early and late drug development. Direct experience in filing global marketing applications and achieving product licensure.
  • 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, e.g. Global, European, International, Marketing Company or experience at a health authority.
  • 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, market entry and license maintenance activities.
  • Ability to travel domestically and internationally.
  • Excellent communication and influencing skillsPreferred:
    • 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 by engaging face-to-face in our offices 3 days a week.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. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.So, what's next!
      • Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.Date Posted: 01-Nov-2024Closing Date: 30-Dec-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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