AstraZeneca
Executive Regulatory Science Director, Respiratory & Immunology
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Join us at AstraZeneca
We are investing in internal capabilities to discover and accelerate the delivery of next-generation respiratory and immunology modalities for patients. As part of our Regulatory Affairs team, you will play a crucial role in bringing these transformative therapies from the lab to life.
Executive Regulatory Science Director, Respiratory & Immunology
Role Overview
The Executive Regulatory Science Director, Respiratory & Immunology should be comfortable interacting with senior leaders, be a tough negotiator, can make decisions in ambiguity, be a decisive leader, and a realist while providing global strategic regulatory expertise and oversight to support products through research, development and commercialization. Their expertise applies to early, late, and post-marketing development stages for respiratory and immunology diseases. They ensure that adequate regulatory resource and skills are provided in line with designated disease area strategies and portfolio to enhance the likelihood of success which meet business needs, health authorities, and patients. They will partner with functions to ensure regulatory experts are assigned to provide strategic regulatory and development advice/direction at the time of key milestone investment decisions across the portfolio.
How You Will Make a Difference
- Provide oversight, partner with, and mentor RADs and SrRADs to produce strategies for a product/group of products in the therapeutic area that are consistent with the disease area and portfolio strategy. The strategies should be crafted and negotiated with global health authorities (e.g., FDA, EMA, CDE) to deliver a rapid approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business and patients.
- Leads discussions in both internal and external forums, providing expertise in regulatory knowledge of disease areas.
- Influences and drives regulatory strategies and recommendations at all stages of development, in early and late development, and for established brands on regulatory components of development specific to respiratory and immunology therapies as well as other tools such as novel endpoints/biomarkers, novel study designs, and digital applications.
- Effectively represent the Regulatory function in senior level interactions at internal governance technical review committees, e.g., Development Review Committee (DRC/eDRC), Early Development Review Board, Global Medical Affairs (GMA) Review Committees.
- Works in collaboration with regional policy and intelligence groups to critically analyze the assessment of emerging science, data, and changes in the regulatory environment.
- Defines and drives disease area global regulatory policies and priorities within the therapeutic area.
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What You'll Need
- An advanced degree in a science-related field plus leadership experience (able to lead other leaders).
- Demonstrated extensive success in regulatory strategy.
- Deep understanding of global regulatory science and integration with program, franchise, and portfolio strategy.
- Broad experience of the therapeutic area: respiratory / immunology expertise is nice to have.
- Experience in global regulatory strategy and submissions that have progressed through to registration.
- Must have significant experience in leading major Health Authority interactions.
- 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 in a matrixed organizational structure.
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Preferred
- Advanced degree in a scientific field (e.g., MSc, PhD, PharmD, MD)
Our Culture
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Diversity and Inclusion
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.
Application Timeline
- Date Posted: 05-Aug-2026
- Closing Date: 04-Aug-2026
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
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