Regulatory Affairs Director - Vaccines and Immune Therapies

Are you a strategically focused Regulatory Affairs professional and would like to play an integral part in shaping drug development and gaining fast, efficient regulatory approvals? If so, read on...

At AstraZeneca, we work with diverse minds, all united by a shared passion to learn, grow and discover.

The Vaccines and Immune Therapies (V&I) group at AstraZeneca is constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We are utilizing our expertise in virology, microbiology and vaccines to enable novel approaches to prevent and treat infectious disease. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules and novel biologics platforms. Within V&I Regulatory Science and Strategy, we take innovative regulatory approaches and work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible.

The Regulatory Affairs Director (RAD) is responsible for providing strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned product(s). The RAD applies knowledge of current local and global regulatory trends to identify future regulatory requirements and strategies and influences regulatory authorities through regular contacts to improve regulatory outcomes.



What you'll do…

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Develop and implement the regional or global regulatory strategy, ensuring it is crafted to deliver rapid approval with competitive labelling that is identified by the business, markets and patients
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Lead the development of the global regulatory strategy document for assigned product(s) and the planning and construction of the global dossier and core prescribing information
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Lead cross functional teams in major regulatory submissions (BLA/MAA/IND/CTA), health authority interactions, label discussions, and securing approvals
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Deliver regulatory milestones for assigned project(s), including the assessment of risks and mitigations, emerging data and the probability of regulatory success
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Ensure effective collaboration across global, regional and local Regulatory Affairs, enabling rapid and effective submissions, approvals and other product maintenance activities
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Participate in skill-development, coaching and performance feedback of other regulatory staff working on the product/project



Essentials for the Role

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Bachelor's Degree in a life science or related field
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Significant experience in early and late-stage regulatory drug development, manufacture, commercialization or equivalent
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Knowledge of regulatory procedures and legislation for drug development, product registration, line extensions and license maintenance
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Proven successful leadership and project management experience



Desirables for the Role

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Previous experience in vaccines or immune therapies is strongly preferred
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Advanced degree in science related field and/or other appropriate knowledge/experience
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Ability to work strategically within a business-critical and high-profile development program
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Critical thinking on current global regulatory science questions and a good understanding of the corresponding scientific and clinical components



Locations: Waltham, MA; Wilmington, DE; Gaithersburg, MD; Durham, NC; Gothenburg and Södertälje, Sweden and Barcelona, Spain.



So, what's next?

Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. Welcome with your application no later than January 22, 2023. As we are approaching a holiday season there might be a slight delay in feedback for your application, we thank you for your understanding.

More information about our sites:

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Gothenburg SE
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Gaithersburg
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Vaccine and Infection



Why AstraZeneca?

AstraZeneca is a global, innovation-driven biopharmaceutical company proud to provide a unique workplace culture that inspires innovation and cross-boundary collaboration. Within this environment employees are empowered to express diverse perspectives, and are made to feel valued, energized and rewarded for their ideas and creativity. There's no better place to see what science can do.