VP, Regulatory Head, Oncology Regulatory Science & Strategy
Shape global regulatory strategy. Accelerate oncology breakthroughs.
Deliver lasting impact for patients.
The Opportunity
Are you ready to set the regulatory vision that accelerates life-changing oncology medicines to patients? As VP, Regulatory Head, you will steer a significant share of our oncology portfolio, partnering with the SVP and senior leaders across science and the business to define strategy at critical milestones and guide portfolio pillars and development programs.
You will lead Executive Directors and Global Regulatory Leaders in delivering integrated, high-impact strategies across small molecules and biologics. Your leadership will translate breakthrough science into globally aligned pathways to approval and access, advance the use of digital and data in regulatory work, and ensure the regulatory voice shapes decisive portfolio choices.
How would you harness regulatory intelligence and external influence to create faster, smarter routes from development to approval and launch?
Key Accountabilities
- Functional leadership and vision: Serve on the leadership team to set the long-term oncology regulatory strategy, translating ambition into clear priorities and measurable outcomes.
- Regional Centre of Excellence: Lead and evolve the Centre to strengthen consistency, capability building, and operational excellence.
- Executive partnership: Deputise for the SVP when required, ensuring continuity of strategy, decisions, and stakeholder engagement.
- Portfolio strategy and execution: Define and align global regulatory strategies for assigned programs, balancing near-term milestones with longer-term investments.
- Digital and data strategy: Advance digital approaches, data use, and automation in regulatory science to accelerate decisions and submissions.
- People leadership and succession: Lead Executive Directors and Global Regulatory Leaders; grow talent, plan succession, and foster a high-performance, learning-focused culture.
- Enterprise decision influence: Embed the regulatory perspective in business and portfolio decisions, shaping trade-offs and risk-benefit choices at governance forums.
- Business development alignment: Partner on in- and out-licensing and external collaborations, ensuring regulatory diligence and strategic fit.
- Regulatory intelligence and policy: Anticipate changes in the regulatory environment and translate insights into proactive program strategies.
- External representation: Represent the company at key forums, including DIA and trade associations, while expanding trusted relationships with global health authorities.
- Submission excellence: Review and approve submission documents, ensuring scientific rigor, clarity, and compliance.
- Best practice and compliance: Champion best practices across therapy areas and uphold policies, procedures, and quality standards.
- Financial stewardship: Manage area budgets and contribute to the function’s financial plan, directing resources to the highest-value opportunities.
Essential Skills & Experience
- PhD in a scientific discipline or equivalent.
- Substantial global experience at the VP or Executive level, or equivalent, delivering positive outcomes across portfolios of varying scientific and clinical complexity, including product approval and launch, with oncology experience and knowledge.
- Broad experience in drug development.
- Strong people and project management experience.
- Successful contribution to a wide range of regulatory approvals at regional or global level.
- Demonstrated track record in portfolio and people leadership from a Regulatory Sciences perspective.
- Established and recognized influential relationships with global health authorities in the relevant disease or therapeutic area.
- Experience serving on key governance committees relevant to the area.
- Experience leading global functional teams, managing change, and building Regulatory Sciences and disease-area capabilities.
- Ability to manage a budget of $10M or more and contribute to the financial plan for ORSS.
Desirable Skills & Experience
- Proven leadership across small molecules and biologics, including combinations and precision medicine approaches.
- Experience shaping regulatory policy through external consortia, trade associations, or guideline working groups.
- Expertise in innovative clinical development approaches, such as master protocols and adaptive designs, and evidence strategies including real-world data.
- Track record of building Centres of Excellence or transformative capability programs across global, matrixed organizations.
- Companion diagnostics experience and fluency in precision oncology regulatory pathways.
- Demonstrated use of digital tools and automation in regulatory operations and intelligence.
- Deep understanding of global regulatory requirements across the FDA, EMA, and key agencies in Asia-Pacific and Latin America.
- Strong public speaking and influencing skills with senior internal stakeholders and external authorities.
Where & How We Work
When we bring unexpected teams together, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace, and challenge perceptions. That is why we work, on average, a minimum of three days per week from the office—while balancing this expectation with individual flexibility. Join us in our unique and ambitious world.
Why AstraZeneca
At AstraZeneca, you will help transform cutting-edge oncology science into meaningful value for patients by bringing unexpected teams together to spark bold ideas and decisive action. You will join an industry-leading regulatory community that shares knowledge across locations and with external partners, applies modern data and technology to shorten development cycles, and balances high ambition with kindness and trust. With a rich pipeline and a culture that empowers ownership, you will shape strategy at scale, influence global standards, and grow your impact while helping deliver therapies that change lives.
Lead the strategy that accelerates oncology breakthroughs.
Step into this role to shape global approvals, grow future leaders, and leave a lasting mark on patient outcomes.
Date Posted
19-Oct-2026Closing Date
25-Oct-2026Our 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.