Executive Regulatory Science & Strategy Director, Oncology

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 (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 anyopportunityno 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 meanswe’reopening new ways to work, pioneering groundbreakingmethodsand bringing unexpected teams together.Interested? Come and join our journey.