Executive Regulatory Science & Strategy Director, Oncology job opportunity at AstraZeneca.

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DateMore Than 30 Days Ago bot
AstraZeneca Executive Regulatory Science & Strategy Director, Oncology
Experience: 10-years
Pattern: full-time
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Oncology

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loacation US - Gaithersburg - MD, United States Of America
loacation US - Gaithersb..........United States Of America

Within Oncology Regulatory Affairs, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to those who need it – working across our pipeline and the business to get medicines to patients as efficiently and optimally as possible. As an industry leading Oncology Regulatory function,   we’re   growing fast, and   we’re   as passionate about and committed to the development of our people as we are our business – providing an open and encouraging space to explore, learn,   grow   and develop across all roles and levels.     At AstraZeneca, we share and are motivated by the same purpose: pushing the boundaries of science   in order to   deliver life-changing medicines to patients around the world. Everything we do is underpinned by our dedication to being a phenomenal Place to Work. We recognize that our people are our greatest asset and know   what’s   possible with an accomplished and diverse team that believes in what science can do.      We are more than 65,000 people in over 100 countries. Our aim is simple: to positively   impact   lives,   together. Using the power of science and innovation, our people improve the impact medicine has on patients. Together, we explore the limitless world of science through our remarkable product pipeline, and we take our understanding of many therapeutic areas to a whole new level by seeking new treatments.     The Executive Regulatory Science   Director   is a role that   provides global strategic regulatory   expertise   and oversight to support the research,   development   and commercialization of products across both small molecules and biologics .     The position that is currently being recruited is   within the Oncology therapy area and specifically leading the Hematology group .       How you will make a difference:   Coach and mentor regional (US and EU regulatory leads) and global regulatory leads, including identification of skill development   opportunities   regulatory professionals with   different levels   of experience.    Partner   with Regulatory   Affairs Directors   aligning on   global innovative regulatory strategies for products .      Lead resource planning and recruitment of staff .     Provide critical review and input on disease area and portfolio regulatory strategies, risk   planning   and mitigations.   Effectively represent the Global Regulatory Affairs function in senior level interactions at   internally   governance technical review committees, key global health authority   meetings   and external partners.   Collaborate with regional policy and intelligence groups to critically analyze the assessment of emerging science, data and changes in the regulatory environment and   advise   senior management on project risks/mitigation activities accordingly.   Define and drive disease   area   global regulatory policies and priorities.   Review and approve high-level documents for global regulatory submissions as well as core prescribing information.   Ensure submission excellence framework is   timely   and consistently applied across projects including sharing the best submission practices and knowledge and using existing tools.   Sponsor key non-drug project workstreams, business initiatives, external activities and meetings and act as a subject matter expert.       What You'll Need:   Bachelor’s degree in life sciences and/or science related field and/or other   appropriate knowledge/experience .   More   than 10   years   drug development experience.   Oncology therapy area knowledge/experience, ideally expertise with Hematology assets.   Deep   knowledge of   global regulatory strategy   experience with all phases of   oncology   drug development ,   including   early drug development as well as   direct   involvement in marketing applications   that have progressed   through to   registration.   Significant experience   in leading major health Authority interactions     Proven experience of   growing   high performance   teams, attracting top talent, and developing capabilities   of regional and global regulatory leads .    Experience in leading people in a matrixed interpersonal 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.     Preferred:    Advanced degree in a scientific subject area ( e.g.   MSc, PhD, PharmD, MD)     Why AstraZeneca?   At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any   opportunity   no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means   we’re   opening new ways to work, pioneering groundbreaking   methods   and bringing unexpected teams together.   Interested ? Come and join our journey.     Competitive salary and benefits package on offer:   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.  The annual base salary in for this position in the US, ranges from $267,000 - 401,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.     Date Posted 19-Dec-2025 Closing Date 30-Jan-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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