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Executive Director, Regulatory Affairs Strategy - Cell Therapy

AstraZeneca -
Barcelona, Barcelona provincia

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Jornada completa

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Microsoft Excel
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Descripción completa del empleo

Posted date Aug. 06, 2026

Contract type Full time

Job ID R-255219

Why choose AstraZeneca Spain?

AstraZeneca Spain is a rising force in our global business. With headquarters in Madrid and our global hub in Barcelona, we’ve become an important international centre of excellence in the fight against critical disease. Boasting vibrant universities and business schools, the Barcelona ecosystem is a place where scientists can thrive. We attract a diverse workforce from across the globe, shining a beacon for innovation in a country that’s committed to clinical development.

We invite you to bring your talents to Barcelona where our respiratory medicine R&D and Global Marketing centre offers opportunities in R&D, IT, Commercial and HR. Or join us in Madrid and shape our growth in our BUs (Respiratory, Oncology & CVRM ), and a range of Corporate functions. Additionally, you can find sales roles throughout the country. Together, we’re contributing to a world-leading pipeline of therapeutics and delivering life-changing medicines to patients.

Who do we look for?

Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca Spain, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. Alongside technical expertise, colleagues have the resilience, energy and collaborative mindset to change lanes, work with different teams and start projects from scratch.

Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Madrid or Barcelona, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day.

Success Profile

Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for.

Diverse collaborators

This is a speak-up culture that values collaboration. You’ll proactively bring your unique perspectives, experiences and skills to the table and seek the same from others. With our international team composition and the need for fast-paced collaboration, you’ll always be building new connections with colleagues.

Cutting-edge innovators

When you join us, you’ll be part of a team that embraces digital technology and data to transform the way we work and the work we do. Every day, you’ll help make history, empowered to ignite your creativity and build something enduring.

Resilient trailblazers

Here, the answers aren’t always available. So, you’ll need to bring a fearless, self-starter mindset to navigate uncharted territories. You’ll harness your ceaseless energy to discover and make the necessary connections with colleagues to shape the future and achieve maximum impact.

Agile movers

Seize ownership and excel with autonomy to enjoy the constant rush of ground-breaking discovery. Your ability to anticipate sudden shifts and adapt swiftly will prove critical as you make your mark in an environment that rewards initiative and resilience.

Responsibilities

Job ID R-255219 Date posted 08/06/2026

Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy

Available locations:

Barcelona, Spain
Amsterdam, Netherlands

Introduction to role:

Are you ready to set the global regulatory direction for first-in-class cell therapies and turn science into approved medicines? Do you see yourself steering complex programs to competitive labels and rapid, global patient access?
This role leads the strategy for our most visible and complex cell therapy programs, translating breakthrough science into timely approvals and meaningful labels that unlock lifecycle value.
You will work across discovery through commercialization, bringing clarity and pace to decision-making and ensuring our therapies reach patients with unmet needs.
You will directly shape how we engage with health authorities, define target product labeling, and accelerate submissions across multiple indications and modalities.
As a senior leader, you will build capability, coach regulatory talent, and influence policy and guidance to sustain a competitive edge for our pipeline and portfolio.

Accountabilities:

Global Regulatory Strategy Leadership: Own the end-to-end global regulatory strategy for a cell therapy product or franchise of exceptional complexity and strategic importance, from current stage through BLA submission, approval, and lifecycle management; may serve in a dual role as Franchise GRL and regional Regulatory Affairs Director.

GPT Representation and Strategic Influence: Represent Regulatory Affairs on Global Product Teams, provide strategic regulatory advice, and be accountable for all regulatory activities that shape development plans, risk management, and commercialization outcomes.

Health Authority Engagement: Lead strategy for major health authority interactions, responses to critical information requests, expedited pathway designations, BLA development and submission, major post-submission interactions, and complex labeling negotiations to secure competitive labels and timely approvals.

External Insight and Policy Shaping: Maintain a deep and current working knowledge of relevant disease areas, evolving scientific evidence, regulatory policy, and the external environment; establish senior external relationships to influence perspectives and maintain competitive advantage.

GRST Leadership and Talent Development: Lead one or more Global Regulatory Strategy Teams focused on indications, programs, or franchise priorities; provide leadership, coaching, and performance feedback; line-manage 3–7 regulatory team members; contribute to succession planning, capability building, and development of senior regulatory talent.

Data-Driven Governance and Risk Management: Deliver objective executive-level assessments of emerging data against program and portfolio aspirations; update senior management on risks, mitigation activities, probability of success, and strategic options.

Milestone Delivery and Dossier Excellence: Be accountable for delivery of all project-related regulatory milestones, including probability of regulatory success assessments, mitigation planning, approval strategy, lifecycle planning; lead preparation of regulatory strategy documents and target product labeling; ensure strong strategic planning and construction of the global dossier and core prescribing information; oversee maintenance and compliance for marketed brands where applicable.

Innovation and Ways of Working: Lead, participate in, and promote major non-project functional or cross-functional initiatives; drive the development and implementation of novel regulatory tools, technologies, and modern ways of working that improve quality and speed.

Cross-Functional and Regional Partnership: Partner with marketing companies, regional regulatory affairs teams, and senior cross-functional stakeholders to influence developing views, guidance, and regulatory policy interpretation; coordinate across therapeutic areas and regulatory teams to deliver our cell therapies to patients.

Essential Skills/Experience:

An advanced degree in a science-related field and at least ten or more years of experience and/or appropriate knowledge/experience.
Demonstrated extensive success in cell therapy regulatory strategy.
Deep understanding of global regulatory science and integration with program, franchise, and portfolio strategy.
Long-standing experience of overall drug/biologic development processes and strategies for high profile, highly complex, novel, or first-in-class development programs.
Experience with product development in the following therapeutic areas: oncology, autoimmune, rare diseases, neurology.
Broad background of experience working in the pharmaceutical business and prior experience in several areas within regulatory affairs.
Proven experience leading regulatory and cross-functional teams, influencing senior stakeholders, and operating effectively in complex matrix environments.
Ability to think strategically and critically at enterprise level and evaluate risks to regulatory and business activities.
Previous significant experience in leading Health Authority interaction in major markets. Excellent oral, written, and presentation skills.
Strong organizational skills. Ability to work in a fast-paced environment in a hands-on fashion.
Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities.
Experience working on due diligence activities and in a business alliance environment.
Experience in leading and growing people through line management, coaching, or mentorship. Contribution to non-project business initiatives at a portfolio, franchise, or enterprise level. Experience contributing to external policy, regulatory science, or industry advocacy initiatives.

Desirable Skills/Experience:

Experience with product development in oncology, autoimmune, rare diseases, and neurology across multiple indications and modalities.
Experience working on due diligence activities and in a business alliance environment.
Experience contributing to external policy, regulatory science, or industry advocacy initiatives.

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.

Why AstraZeneca: Here, transformative science meets decisive execution. You will help convert cutting-edge cell therapy innovation into globally approved medicines for patients with unmet needs, working in a connected, inclusive environment that values kindness alongside ambition.

We bring diverse experts together to spark bold ideas, apply modern regulatory approaches, and harness data and technology to shorten development cycles. With a rich pipeline and empowered teams, your leadership will shape labels, accelerate access, and create lasting impact for patients worldwide.

Call to Action:

Step into a role where your regulatory leadership defines the path from discovery to approval—take the lead and shape the future of cell therapy today!

Date Posted

06-Aug-2026

Closing Date

30-Aug-2026

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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Reasons to Join

Thomas Mathisen

There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.

Sales Representative Oslo, Norway

Christine Recchio

Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.

Sales Representative California, United States

Stephanie Ling

There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.

Sales Representative Petaling Jaya, Malaysia

What we offer

We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, inclusivity, balance and sustainability. Discover what a career at AstraZeneca could mean for you.

An award-winning company

We're passionate about being a great place to work, and 84% of our employees would recommend us as an employer. We've been recognised as a Top Employer in Spain, an EFR Family Responsible Business, and we achieved third place in Forbes Spain's Top 50 Best Places to Work list.

Inclusive environment

Diversity and inclusion are embedded in everything we do, and our different views, experiences and strengths enrich our culture. There's no salary gap at AstraZeneca, and the number of female employees has increased by four per cent over the last three years. We've also made all positions fully accessible.

Work-life balance

Your wellbeing means a lot to us, and we're here to support you through all of life's ups and downs. That's why we offer an unpaid leave policy, annual leave, reduced-hours timetables and a host of benefits, including a retirement plan, long service award, and health and travel insurance.

Sustainability initiatives

We're committed to harnessing the power of science to become a more sustainable business. We've reduced our carbon footprint by over 9,000 kg of CO2 over the last two years, and we lead the European GoGreen Project, which aims to introduce environmentally friendly options in our fleet of corporate vehicles.

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