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Plats: Gaithersburg, Maryland, USA Cambridge, England, Storbritannien
Jobb-id R-052027
Datum inlagd: 05/30/2019

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 Regulatory Affairs Director you'll 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

We are currently looking to hire a Regulatory Affairs Director (RAD) to join our Global Regulatory Affairs team in Respiratory. 

As the Regulatory Affairs Director, you will be accountable for the development and implementation of the regulatory strategy for a product or group of products and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labelling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.

As the Regulatory Affairs Director you will possess strategic leadership skills and have an understanding of regional (US or EU) and/or global regulatory science and overall drug/biologic development processes and strategies.

To have experience and knowledge of the disease area is an important enabler to being able to influence cross-functional discussions with regional and/or Global Product Teams (GPT), Investigational Product Teams (IPT) and relevant stakeholders.  

You will have the ability to take on the Global Regulatory Lead (GRL) role for a product/group of products.

Additional duties will also include leading and developing a regional and/or global regulatory strategy that is reflective of applicable domestic and international requirements, leading the planning and construction of the global dossier and core prescribing information and leading the development and implementation of innovative strategies to maximize the likelihood of regulatory success.

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 be able to demonstrate the following competencies:
- 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. 

Regulatory Affairs Director (RIA)
Regulatoriskt

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.

Learn more

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