Senior Director/ Director Regulatory Affairs - Late R&I

Do you have expertise in, and a passion for Regulatory Affairs? Would you like to apply your expertise in designing unique regulatory strategies for our early phase portfolio, applying innovative methods from its inception to impact the development of new medicines for the treatment of Respiratory and Immunology diseases? Do you have innate ability to interact with project teams and senior leaders to communicate and convey your ideas? Then this position might be the one for you!

We continue to expand our regulatory teams at AstraZeneca's dynamic R&D sites in Gaithersburg and Durham (US), Gothenburg (Sweden) and Cambridge (UK).

This role seeks an experienced Regulatory Affairs professional with experience in providing strategic and operational regulatory leadership to the development of our early phase portfolio which includes a high priority asset waiting for the opportunity to champion, but also a vision to maximize the commercialization and life cycle management. You will define the regulatory strategy for our therapeutic assets, and engage with Health Authorities to effectively inform our development programs, and seek to shape the environment of novel and unique approaches, endpoints etc. to ultimately produce a competitive label longer-term.

To be considered for the Senior Regulatory Affairs Director role, candidates should be recognized as an expert in Regulatory Affairs and have a proven track record of driving unique regulatory strategies, innovation, and accelerating and transforming key processes. Experience in designing early phase programs desired.



What You'll Do:

In combination with your regulatory expertise, successful candidates will demonstrate competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills. It is important that you embrace the concepts of novel regulatory tools and technology as well as a culture of sharing experiences with others so that the medicines that we develop will benefit from latest approaches in regulatory science. You are comfortable speaking the regulatory voice throughout the organization.

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Provides strategic regulatory advice support for product developments regional therapy area, or as GRL, influences the global regulatory strategy, with a focus towards innovation and acceleration of drug development to submission.
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Ensures adequate risk assessments and mitigation plans are considered in the regulatory strategy and captured in relevant documents and via communication through project teams.
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Analyzes opportunities, risks, strengths and weaknesses of a program or process, with a future-looking view.
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Drives continuous improvement and seeks opportunities for sharing.



Essential for the Role:

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Academic degree in a science related field or equivalent
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Extensive knowledge of regulatory affairs with a proven track record of regulatory drug development with a focus on early phase programs and an eye towards submission, product approval/launch.
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Capability to apply knowledge of current local and global Regulatory trends to identify future regulatory requirements and strategies. Influences Regulatory authorities through regular contacts to improve Regulatory outcomes. Influence landscape on new approaches to drug development and novel endpoints
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Ability to manage multiple early phase programs at one time, contributing to preparation for governances and defending ideas for implementation.



At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together.



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 May 31st 2022.

We will review the applications continuously so please apply as soon as possible.



Where can I find out more?

Curious about Regulatory at AstraZeneca?

AZ Gothenburg: https://www.astrazeneca.com/our-company/our-locations/gothenburg.html

AZ Gaithersburg: https://www.astrazeneca.com/our-company/our-locations/gaithersburg.html

AZ Cambridge: https://www.astrazeneca.com/our-company/our-locations/cambridge.html