Director, Global Regulatory Affairs

Meaningful Impact. Make a more meaningful contribution Impact patients’ lives every day

Make a more meaningful impact in your career, with greater ownership and accountability to make a contribution. And in return… we’re looking for people driven by making a difference to patients’ and society, dedicated to doing the right thing.

What we do

We are reshaping our organisation to thrive in a complex and ever-changing world. Evolving to become a learning organisation – ready and equipped to embrace the challenges and seize the opportunities that lie ahead.

Why we love it

This is the place to make an impact. Here we ensure everyone can reach their full potential, perform at their best and make a valued contribution to the enterprise.

What you’ll do

AstraZeneca’s 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 AstraZeneca’s 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 responsibilities

As 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 we’re opening new ways to work, pioneering ground-breaking methods and bringing unexpected teams together. Interested? Come and join our journey.

Salary: Competitive

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

Applications open on 6th October 2021 and we welcome your CV and cover letter no later than 6th November 2021.

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

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. Covid-19 Resources

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.

More information about our sites:

More Information

Privacy Policy / BBSTEM Limited | Registered in England and Wales | Company No: 11127036