AstraZeneca
Senior Regulatory Affairs Group Director, Late CVRM
Boston, MA
Sep 17, 2024
fulltime
Full Job 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 seeking a dynamic and experienced Senior Regulatory Affairs Group Director (SrRAGD) to join the Regulatory Affairs Management (RAM) group supporting the CVRM Therapeutic Areas. In this role, you will play a pivotal role in developing and shaping the strategic direction of the group, ensuring improved efficiency, performance, and quality of the RAM community. You will also be part of leading and developing the broader Late CVRM Regulatory team, driving our vision of being an industry-leading regulatory organization and a great place to work.

What You'll Do

  • Provide leadership, coaching and line management for a group of Regulatory Affairs Managers based in Boston and Mississauga

  • Ensure efficient, targeted recruitment for the group and lead talent and performance development activities

  • Collaborate with the RAM leadership team to set the strategy for tactical delivery and efficiency for drug projects

  • Drive improvement projects and embed change in the organization

  • Establish and develop relationships with key stakeholders, internally and externally

Essential For the Role

  • Bachelors Degree in Science or related discipline

  • 10+ years' experience in regulatory affairs in the pharmaceutical industry or at a health authority

  • Knowledge of regulatory procedures and legislation for drug development throughout the product lifecycle

  • Extensive experience in managing people and organisations in a matrixed organizational structure

  • Excellent collaboration, team working, oral and written communication skills

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

13-Sep-2024

Closing Date

03-Oct-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.PDN-9d083419-bf2d-4ae0-84fd-a83f00e85084
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Senior Regulatory Affairs Group Director, Late CVRM
AstraZeneca
Boston, MA
Sep 17, 2024
fulltime
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