Company Profile:

At AstraZeneca's Oncology Business Unit, we’re all here to make an impact – to achieve our bold ambition of eliminating cancer as a cause of death. We relentlessly follow the science, challenging the status quo to deliver more effective treatments to patients in need. Our dedication means we purposefully push back the limits of knowledge to change the practice of medicine. To ensure no patient is left behind, no matter what stage of disease. We’re brave disruptors – entrepreneurial, adventurous and pioneering in our approach. Here you have the opportunity to step up, take personal accountability and lead changes in our ever-evolving environment.

Job description:

Job Title: Regulatory Affairs Director

Career Level - F

 

Introduction to Role:

Are you ready to apply your Regulatory Affairs strategy expertise to make a real difference? At AstraZeneca, we follow the science and turn ideas into life changing medicines. We do this with the utmost integrity, even in the most complex situations, because we are committed to doing the right thing. We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s exceptional skills with those of people from all over the globe. As part of our Oncology Regulatory Science Strategy and Excellence (ORSSE), we bring hope and solutions to patients with unmet needs. We work across our ground-breaking pipeline and the business to get medicines to patients as efficiently and optimally as possible.

 

Accountabilities:

As a Regulatory Affairs Director (RAD), you will provide strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products. You will serve either as the global regulatory lead (GRL) and/or as the regional regulatory lead. You will play a substantial role in crafting and implementing the clinical strategy and influencing health authorities to improve outcomes.

 

Essential Skills/Experience:

• Bachelor's degree in a science related field with at least 3 years of Regulatory strategy or related knowledge/experience.

• A solid understanding of regulatory affairs within at least one therapeutic area in both early and late development, preferably oncology (small molecules & biologics)

• Previous experience of regulatory drug development or equivalent, and experience with major HA interactions.

• Demonstrated competencies of critical thinking, strategic influencing, risk evaluation, innovation, initiative, leadership skills and strong communication skills.

 

Desirable Skills/Experience:

• Not applicable

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.