Executive Regulatory Science & Strategy Director, Oncology

AstraZeneca•Gaithersburg, MD

12d

About The Position

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 .

Requirements

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.

Nice To Haves

Advanced degree in a scientific subject area ( e.g. MSc, PhD, PharmD, MD)

Responsibilities

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.