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Director, Global Regulatory Affairs

Company: AstraZeneca
Location: Gaithersburg
Posted on: October 19, 2020

Job Description:

Regulatory Affairs Director

Feel valued for your influential work in shaping drug development and gaining fast, efficient approvals. We are pro-actively involved in the strategy, changing the course for approvals and influencing regulators on new technology. Without us, our ground-breaking science wouldnt have half the impact.

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being results-oriented 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 youre our kind of person.

AstraZenecas pipeline of innovative medicines is consistently growing within both Cardiovascular, Renal and Metabolism (CVRM) and Respiratory and Immunology (R&I) two of our major therapy areas. To meet the increasing demand of regulatory expertise, we continue to expand our regulatory functions through the recruitment of strategically focused Regulatory Affairs professionals . 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 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 continue to expand our regulatory teams at AstraZenecas dynamic R&D sites in Gothenburg, Sweden, Cambridge, UK, Gaithersburg, US and Durham, US. 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.Main duties and responsibilitiesAs a Regulatory Affairs professional within AstraZeneca, you will play a key role in channelling 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.

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.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 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 at all levels of the organisation.


  • Academic degree in a science related field or equivalent
  • 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.

    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 recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means were opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.

    We are eager to know more about you. If you are interested to know more about us, apply now!

    We welcome your application no later than 30th October 2020.

    Please apply as soon as possible as we will be continuously screening and interviewing candidates. Thank You!

    We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Keywords: AstraZeneca, Washington DC , Director, Global Regulatory Affairs, Executive , Gaithersburg, DC

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