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’regrowing fast, andwe’reas passionate about and committed to the development of our people as we are our business – providing an open and encouraging space to explore, learn,growand develop across all roles and levels.
At AstraZeneca, we share and are motivated by the same purpose: pushing the boundaries of sciencein order todeliver 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 knowwhat’spossible 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 positivelyimpactlives,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 ScienceDirectoris a role thatprovides global strategic regulatoryexpertiseand oversight to support the research,developmentand commercialization of products across both small molecules and biologics. The position that is currently being recruited iswithin 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 developmentopportunitiesregulatory professionals withdifferent levelsof experience.
Partnerwith RegulatoryAffairs Directorsaligning onglobal innovative regulatory strategies for products.
Lead resource planning and recruitment of staff.
Provide critical review and input on disease area and portfolio regulatory strategies, riskplanningand mitigations.
Effectively represent the Global Regulatory Affairs function in senior level interactions atinternallygovernance technical review committees, key global health authoritymeetingsand external partners.
Collaborate with regional policy and intelligence groups to critically analyze the assessment of emerging science, data and changes in the regulatory environment andadvisesenior management on project risks/mitigation activities accordingly.
Define and drive diseaseareaglobal regulatory policies and priorities.
Review and approve high-level documents for global regulatory submissions as well as core prescribing information.
Ensure submission excellence framework istimelyand 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 otherappropriate knowledge/experience.
Morethan 10yearsdrug development experience.
Oncology therapy area knowledge/experience, ideally expertise with Hematology assets.
Deepknowledge ofglobal regulatory strategyexperience with all phases ofoncologydrug development,includingearly drug development as well asdirectinvolvement in marketing applicationsthat have progressedthrough toregistration.
Significant experiencein leading major health Authority interactions
Proven experience ofgrowinghigh performanceteams, attracting top talent, and developing capabilitiesof 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, marketentryand license maintenance activities.
Ability to travel domestically and internationally.
Preferred:
Advanced degree in a scientific subject area (
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-2025Closing Date
30-Jan-2026Our 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.