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Senior Director Regulatory Affairs, Late Cardiovascular, Renal and Metabolism
Location:
Boston, MA
Description:
Are you passionate about science and experienced within regulatory affairs and drug development ? Do you possess strategic and operational leadership skills? Then, join us at Cardiovascular, Renal or Metabolism (CVRM) regulatory affairs to get involved in the global regulatory strategies and support the research, development and commercialization of our products across the portfolio!AstraZeneca's pipeline of innovative medicines is consistently growing within Cardiovascular, Renal and Metabolism (CVRM). Within CVRM Regulatory Affairs we take innovative regulatory approaches to bring these CVRM life-changing treatments to those who need it - working across our early and late-stage development pipeline and the business as efficiently and effectively as possible. As an industry leading CVRM Regulatory function, we're focused and committed to the development of our products as well as to our people - providing an open and supportive space to explore, learn and develop across all regulatory roles and levels.We are more than 65.000 people in over 100 countries. Our aim is simple to positively impact lives together. Using the power of science and innovation, our people improve the impact medicine has on patients. Together, we explore the world of science through our remarkable product pipeline and we take our understanding of the CVRM therapeutic area to a whole new level by seeking new treatments. What You'll do 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 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. Essential for the role 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 organization. Bachelors degree in a science related field. 3+ years of proven experience defining and implementing the regulatory strategy for a pharmaceutical organization. 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. 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 recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're 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! As AstraZeneca continues to put patients at the forefront of our mission, we are excited for our move to Kendall Square/Cambridge in 2026. Find out more information here: Kendall Square Press Release Date Posted 06-May-2024 Closing Date 30-May-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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