Regulatory Affairs Strategy Director
US - Gaithersburg - MD On-site
$186,233–$279,349 a yearJobFig found this opening at its original source and checks that it remains available.
About the role
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! The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned products. Serves as the global regulatory lead (GRL) on projects or specific indications of larger programs and/or as the regional regulatory lead. The RAD plays a substantial role crafting and implementing the clinical strategy and influencing health authorities to improve outcomes. 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. 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 this way, our Regulatory Affairs teams are transforming exciting science into valued new medicines for patients around the world. 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.
What you'll bring
- 5+ 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.