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Regulatory Affairs Strategists, CVRM and RIA

Location Gaithersburg, Maryland, United States Job ID R-063565 Date posted 12/05/2019

Regulatory Affairs Strategists, CVRM and RIA

Are you an experienced Regulatory Affairs professional with strategicleadership skills and a deep understanding of global regulatory science in the context of drug development?  Would you like to apply your expertise in a global company where we work together across boundaries to make the impossible a reality? If so, you might be interested in joining us to be part of the development of innovative treatment of diseases in the areas of Cardiovascular, Renal and Metabolic (CVRM) or Respiratory, Inflammation and Autoimmunity (RIA)!

AstraZeneca’s pipeline of innovative medicines is consistently growing within both CVRM and RIA, two of our major therapy areas. To meet the increasing demand of regulatory expertise, we are now expanding our regulatory functions by recruiting Regulatory Affairs Strategists. With us, you will get 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 disciplines in an atmosphere of collaboration and inclusion where Regulatory affairs is a respected voice and considered an equal partner.

 If you are looking for a new challenge, we are offering opportunities in different disease areas and at different levels, depending on your expertise and previous experience. We are now expanding our regulatory teams at AstraZeneca’s dynamic R&D site in Gaithersburg, US. You can also be located in Cambridge, UK or Gothenburg, Sweden depending on your preference.

Main duties and responsibilities

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 define the regulatory strategy for our innovative pipeline, influence the development of our therapeutic assets and execute against the health authority engagement and submission plan globally, thereby transforming exciting science into valued new medicines and ensuring patients around the world can access them.

Strategic thinking is key within our function. The more experienced you are, the more accountability you will have for strategic leadership including responsibility for development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.


In combination with your regulatory expertise, you 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 concept 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 at all levels of the organization.

  • Academic degree in a science related field or equivalent
  • Solid knowledge of regulatory affairs within one or more therapeutic areas in early and late development
  • Considerable experience 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 eager to know more about you. If you are interested to know more about us, apply now!

Additional information

Our Gaithersburg site:

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.

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