Senior Regulatory Affairs Director (Cardiovascular, Renal & Metabolism)

Göteborg - Sweden

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Lead the Regulatory Vision for projects in AstraZeneca CVRMs 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 AstraZenecas 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 youre our kind of person.

About the Role

As a Senior Regulatory Affairs Director youll 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 AstraZenecas 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 were dedicated to being a Great Place to Work. Youll 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)

Theres 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.

Required Experience:

Director

Lead the Regulatory Vision for projects in AstraZeneca CVRMs exciting portfolioAre you a seasoned regulatory strategist ready to shape the future of Regulatory while guiding innovative medicines from development through to patients worldwide Join AstraZenecas Cardiovascular Renal & Metabolism (CVRM)...