Executive Regulatory Science & Strategy Director, Oncology

AstraZeneca

1d • Hybrid

About The Position

Within Oncology Regulatory Affairs, AstraZeneca focuses on areas of unmet need, employing innovative regulatory approaches to deliver life-changing treatments efficiently and optimally. The company is an industry-leading Oncology Regulatory function, experiencing rapid growth, and is committed to the development of its people, fostering an open and encouraging environment for exploration, learning, growth, and development across all roles and levels. AstraZeneca's purpose is to push the boundaries of science to deliver life-changing medicines to patients globally, underpinned by a dedication to being a great place to work. With over 65,000 people in more than 100 countries, the aim is to positively impact lives through science and innovation, exploring a remarkable product pipeline and seeking new treatments across various therapeutic areas. The Executive Regulatory Science Director role provides global strategic regulatory expertise and oversight for the research, development, and commercialization of small molecules and biologics. This specific position is within the Oncology therapy area, leading the Hematology group. AstraZeneca encourages an entrepreneurial spirit, seeking opportunities for change and pioneering groundbreaking methods by bringing unexpected teams together. The company is a global, science-led, patient-focused biopharmaceutical company dedicated to discovering, developing, and commercializing prescription medicines for serious diseases. It strives to be a Great Place to Work, empowering employees to challenge convention, unleash entrepreneurial spirit, embrace differences, and drive change to meet global healthcare and sustainability challenges. AstraZeneca fosters an inclusive and equitable environment where diversity drives innovation, leading to breakthrough ideas and life-changing medicines. The organization is curious about science, creative in problem-solving, and driven to make responsible choices, focusing on people and their potential to make a difference in medicine, patients, and society.

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.

Benefits

• Competitive salary and benefits package
• Individualized flexibility in ways of working
• Short-term incentive bonus opportunity
• Eligibility to participate in our equity-based long-term incentive program (salaried roles)
• Eligibility to receive a retirement contribution (hourly roles)
• Qualified retirement program [401(k) plan]
• Paid vacation
• Paid holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Number of Employees: 5,001-10,000 employees