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Director, Global Regulatory Affairs - Covid-19

Location Waltham, Massachusetts, United States Durham, North Carolina, United States Cambridge, England, United Kingdom Gaithersburg, Maryland, United States Job ID R-098393 Date posted 03/03/2021

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

AstraZeneca’s pipeline of innovative medicines is consistently growing within Respiratory and Immunology (R&I). To meet the increasing demand of regulatory expertise, we continue to expand our regulatory functions through the recruitment of strategically focused Regulatory Affairs professionalsWith us, you will have the opportunity to work across the spectrum of drug development to progress a rich and diverse pipeline of both small and big molecules. You will work across multiple therapy areas in an atmosphere of collaboration and inclusion where Regulatory Affairs is a respected voice and considered an equal partner in the business.

We are looking for passionate colleagues to join our team as a Regulatory Affairs Director.

Requirements

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 novel regulatory tools and technology so that the medicines we develop will benefit from latest approaches in regulatory science.

You are comfortable speaking the regulatory voice at all levels of the organisation.

  • Academic degree in a science related field such as infectious diseases and vaccines
  • Extensive knowledge of regulatory affairs within one or more therapeutic areas in early and late development
  • Proven track record of regulatory drug development including product approval/launch.
  • Successful leadership to at least one major regulatory approval at a global level is required for senior positions.
  • Experience in leading Major Health Authority interactions
  • Ability to think strategically and critically and evaluate risks to regulatory activities.
  • Ability to work strategically within a complex, business critical and high-profile development program.

We are working towards our aspiration to make AstraZeneca the place to build a career in Regulatory. Here we inspire and support to help drive your professional and personal growth and development.

At AstraZeneca we foster a recognition culture that celebrates successes and provides exciting opportunities for those with the drive to achieve. Your development is something we passionately support.

Our culture

Working on a strong pipeline means so much more than producing innovative, ground-breaking medicines. It allows us to be part of long-term development programs with the variety that comes from working at the leading edge of science and technology.

We explore innovations and confront challenges that others won't in order to have a greater impact on patients' lives.

With us you will get the opportunity to work with a diverse portfolio in a global and innovative settings, such as digital science and novel therapeutic modalities while contributing to our robust pipeline.

So, what’s next?

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

We welcome your application, CV and cover letter, no later than 31st March, 2021

For more information please contact Alexander.doyle@astrazeneca.com

These roles can be based at either of AstraZeneca’s vibrant R&D sites in Cambridge (UK), Boston (US), Durham (US), Waltham (US), Gaithersburg (US) or Gothenburg (Sweden),

Salary will be competitive

Additional information

Our Company Values & Behaviors underpin everything we do so please take a moment to familiarize yourself with them. You may also want to check out our new R&D Video showing how we turn Science into Medicines. Covid-19 Resources

More information about our sites:



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 authorisation and employment eligibility verification requirements.

10001196 F RGPD R&D BioPharmaceuticals

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.