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Location:
Gaithersburg, Maryland, United States
Gothenburg, Västra Götaland County, Sweden
Cambridge, England, United Kingdom
Job reference: R-052023
Posted date: May. 30, 2019
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Location: Cambridge in the UK or Gothenburg in Sweden or Gaithersburg in US

Competitive salary and benefits

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

As a Senior Regulatory Affairs Director, you will play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients’ lives. Our regulatory team drives development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.

Main Duties and Responsibilities

As the Senior Regulatory Affairs Director, you will be accountable for leading the development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.

You will also ensure that the strategy is designed to deliver rapid approval with advantageous labelling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.

You will show strategic leadership skills, and a deep understanding of global regulatory science and overall drug/biologic development processes and strategies for high profile, complex or novel development programs.

You will lead the planning and construction of the global dossier and core prescribing information and you will conduct regulatory risk planning and mitigation.

You will lead the Global Regulatory Strategy Team (GRST) with key contributing members from a regional perspective, emerging markets, RA CMC as well as delivery & enablement and be accountable for the delivery of all regulatory milestones including assessment of the probability of regulatory success together with risk mitigation measures. 

You will also be accountable for product maintenance, supply and compliance activities associated with marketed brands and you will lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities. 

You will partner with marketing company and regional regulatory affairs staff to influence developing views/guidance and you will provide leadership and participate in coaching, and performance feedback to members of your GRST.

Essential Requirements

  • Advanced degree in a science related field and/or other appropriate knowledge/experience.
  • Must have previous experience in leading Major Health Authority interactions.
  • Considerable experience of regulatory drug development including product approval/launch.
  • Expert knowledge of regulatory affairs within one or more therapeutic areas.
  • Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
  • Experience in relevant therapy area (small molecules & biologics) is preferred.
  • Proven leadership experience.
  • Ability to think strategically and critically evaluate risks to regulatory activities.
  • Ability to work strategically within a complex, business critical and high-profile development program.
  • Successful contribution to a major regulatory approval at a global level.
  • A scientific and clinical understanding of the regulatory sciences.
  • Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.

If you are interested in this position, please apply by submitting your CV.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. 

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Senior Regulatory Affairs Director (RIA)
Regulatory

AstraZeneca in the UK

Our 6,700-strong UK workforce is based across seven sites in the UK, including our new research facilities and global corporate headquarters in Cambridge. The Cambridge Biomedical Campus (CBC) is globally renowned as a leading centre of research, education and patient care. For AstraZeneca, the campus is the perfect environment in which to foster a vibrant culture of open innovation and collaboration.

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