Director, Global Regulatory Affairs - R&I

Are you passionate about science and experienced within regulatory affairs and drug development? Do you possess strategic and operational leadership skills? Then, join us at Respiratory and Immunology (R&I) regulatory affairs to get involved in the global regulatory strategies and support the research, development and commercialization of our products across the portfolio!

At AstraZeneca, we aspire to be pioneers in science, leading in our disease areas and truly transform patient outcomes. This means our people are here to win, we give you a breadth of opportunities to be curious and do cutting edge, unique work that has significant impact on science, medicines and patients.

The Global Regulatory Affairs Therapeutic area team, that you will belong to, is a strategic function within the Respiratory & Immunology Development organisation. The Regulatory Affairs team leads the development and execution of regulatory strategies for global programmes across the entire lifecycle by proactively leveraging and applying the broad regulatory and scientific expertise, leadership skill and business acumen to identify and champion innovative and impactful regulatory pathways and drug development strategies to benefit patients.



The role

We now have a great opportunity for you to join our team within Respiratory and Immunology (R&I) in the role as Global Regulatory Affairs Director. This role can be based at AstraZeneca's dynamic R&D sites in Gothenburg (Sweden) or Barcelona (Spain).





What you'll do

As a Regulatory Affairs professional within AstraZeneca, you will play a key role in channeling our scientific capabilities to make a positive impact on changing patients' lives. In Regulatory Affairs, our teams influence the development of our innovative pipeline, define the regulatory strategy for our therapeutic assets, and engage with Health Authorities to effectively inform our development programs. In this way, our Regulatory Affairs teams are transforming exciting science into valued new medicines for patients around the world.

The Global Regulatory Affairs Director is accountable for leading the development and implementation of the global regulatory strategy for a project or a group of products of increasing complexity within the R&I portfolio. You will ensure that the strategy is designed to deliver rapid approval with advantageous labelling in keeping with the properties of the products and the needs identified by the business, markets and patients.



Do you have the essential qualifications for this role?

In combination with your regulatory expertise, the successful candidate 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 the latest approaches in regulatory science. You are comfortable speaking the regulatory voice at all levels of the organization.



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Advanced academic degree in a science related field
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Extensive knowledge of regulatory affairs within one or more therapeutic areas in early and late development (more than 7 years)
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Proven track record of regulatory drug development including product approval/launch.
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Ability to work strategically within a complex, business critical and high-profile development program.



To be a successful in this role, we believe that you have a broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority. Previous experience in leading Major Health Authority interactions (e.g. FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.) would be an advantage.



Desirable Requirements:

Experience and knowledge within the Respiratory or Immunology disease areas is an advantage, but not a formal requirement.



So, what's next?

Are you already imagining yourself joining us? Good, because we can't wait to hear from you!



Welcome with your application no later than 19 February. We will review the applications continuously so please apply as soon as possible.



Where can I find out more?

AZ Gothenburg

Respiratory & Immunology