Executive Director, Global Regulatory Science & Strategy - Oncology at AstraZeneca in Gaithersburg, Maryland

Job Description:

Are you a strategically focused Regulatory professional with global leadership experience that would like to play an integral part in bringing life changing oncology medicines to patients? If you are please read on...


AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that discovers, develops and commercializes ground-breaking medicines for some of the world's most serious diseases. We explore innovations and confront challenges that others won't, to have a greater impact on patient lives. Working on a strong pipeline means much more than producing innovative, ground-breaking medicines. Our vision is to change the face of our industry for good and to redefine the careers of our people. We're committed to a culture of continuous learning and people development so everyone at AstraZeneca can grow and thrive.


The Executive Director, Regulatory Science & Strategy provides global strategic regulatory expertise and oversight to support the research, development and commercialization of products across both small molecules and biologics within the Oncology Regulatory Science and Strategy (ORSS) group. This role will involve oversight of fast paced, innovative projects. More specifically, the position will:

• Provide critical review and input on multiple oncology disease area and portfolio regulatory strategies, risk planning and mitigations. The strategies should be crafted and negotiated with global health authorities to deliver a rapid approval with competitive labelling in keeping with the properties of the product(s) and the needs identified by the business and patients.


• Define and drive disease area global regulatory priorities and play an essential role in shaping Astra Zeneca's approach to emerging global oncology initiatives.


• Review and/or approve critical documents with regulatory intent, including briefing documents for health authority interactions, high-level documents for global regulatory submissions as well as core prescribing information.


• Ensure timely and high-quality marketing applications using existing tools as well as sharing the best submission practices and knowledge.


• Effectively represent the Global Regulatory Affairs function in senior level interactions at internal governance technical review committees, key global health authority meetings and with external partners.


• Lead, develop and coach Regulatory Affairs Directors (US and EU regional regulatory leads) and Senior Directors (global regulatory leads), as well as recruit new staff. Foster an open and transparent environment that maximizes the potential of staff.


• Collaborate with regional policy and intelligence groups to critically analyze emerging science, data and changes in the regulatory environment and advise senior management on project risks and mitigations activities accordingly.

Minimum Qualifications:

• Bachelor's degree in life sciences or related field


• A minimum of 10 years of proven experience in strategic drug development.


• Deep oncology therapy area knowledge, including understanding of scientific, medical and regulatory environments.


• Varied experience in global regulatory strategy across the phases of drug development, including both early and late drug development. Direct experience in filing global marketing applications and achieving product licensure.


• Significant experience in leading major health authority interactions in major markets


• Broad background of experience working in pharmaceutical/medical industry and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.


• Experience in managing people both directly and in a matrixed organizational 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.


• Excellent communication and influencing skills

Preferred:

• Advanced degree in a scientific subject area.


• Experience working within an alliance.

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 for this position in the US ranges from $266,093 to $399,140. 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.



Why AstraZeneca?



At AstraZeneca we're dedicated to being a phenomenal place to work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.



So, what's next!

• Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Apply Now