Senior Regulatory Affairs Director (Cardiovascular, Renal & Metabolism)

Lead the Regulatory Vision for projects in AstraZeneca CVRM’s exciting portfolio

Are you a seasoned regulatory strategist ready to shape the future of Regulatory while guiding innovative medicines from development through to patients worldwide? Join AstraZeneca's Cardiovascular, Renal & Metabolism (CVRM) team as a Senior Regulatory Affairs Director and become a recognized leader who drives regulatory excellence within our function and across the broader regulatory community.

About AstraZeneca

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.

About the Role

As a Senior Regulatory Affairs Director, you’ll lead the regulatory strategy for large and complex drug development projects or programs/franchises spanning multiple indications as Global Regulatory Lead (GRL), Franchise GRL, or in a dual role as GRL and Regional Regulatory Lead.In your role as a Senior RAD you will also contribute to shaping the future of our Regulatory function through mentorship, innovation, and external thought leadership.

This senior role distinguishes itself through:

• Franchise-level leadership across multiple indications and development programs (vs. single project/indication focus)

• Dual capacity to serve as both GRL and Regional Lead as required

• Mentorship and coaching responsibility for developing regulatory talent and building team capabilities

• External thought leadership establishing you as a recognized voice in the regulatory community

• Functional innovation driving the development of novel regulatory tools, technologies, and approaches

Strategic Leadership at Scale

• Lead the development and implementation of the global regulatory strategy for complex projects or franchises with multiple indications and development programs, ensuring rapid approval with competitive labeling that meets patient, market, and business needs

• Lead the Global Regulatory Strategy Team (GRST) which may include other GRLs responsible for specific indications, and experts across regions and Regulatory skill groups

• Represent Regulatory Affairs on Global Product Teams (GPTs) or Franchise leadership teams, providing strategic regulatory counsel that shapes overall product and clinical strategy

• Serve as a thought leader at industry conferences, regulatory forums, and trade organizations, representing AstraZeneca's regulatory excellence externally

Foster a culture of strategic thinking, innovation, and regulatory excellence

Essential Experience & Qualifications

• Advanced degree in a science-related field and/or equivalent knowledge/experience

• 7-10 years of regulatory drug development experience including product approval and launch

• Proven track record of leading at least one major regulatory approval at a global level, including response team leadership and labeling negotiations

• Extensive experience leading major Health Authority interactions

• Deep knowledge of regulatory affairs spanning both early and late development in one or more therapeutic area(s)

• Demonstrated leadership in complex, business-critical, high-profile development programs

Essential Skills & Competencies

• Strategic thinking with the ability to critically evaluate risks and opportunities across a franchise

• Strong influencing skills with proven ability to drive alignment at senior levels both internally and externally

• Excellent communication abilities, both written and oral, with confidence presenting to executive leadership, regulatory agencies, and external audiences

• Innovation mindset with initiative to challenge conventional approaches and drive functional advancement

• Mentorship capability with track record of developing regulatory talent

Why AstraZeneca?

At AstraZeneca, we're dedicated to being a Great Place to Work. You'll be empowered to push the boundaries of science and unleash your entrepreneurial spirit. We offer:

• Impact: Direct influence on medicines that change patient lives

• Collaboration: An inclusive culture that champions diversity and values Regulatory Affairs as an equal partner

• Growth: Commitment to lifelong learning and career development

• Innovation: Work on a rich and diverse pipeline of both small and large molecules

• Flexibility: Individualized ways of working that balance personal and professional commitments (3 days per week in office)

There's no better place to make a difference to medicine, patients, and society. Join us on our exciting journey to pioneer the future of healthcare.

Date Posted

02-Apr-2026

Closing Date

29-Apr-2026

Our 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.