Senior Director, Regulatory Affairs Strategy - Cell Therapy

AstraZeneca; Amsterdam; In loco; EUR 150.000 - 210.000; Tempo pieno

Descrizione del lavoro

AstraZeneca plc is seeking a strategic and hands-on Global Regulatory Leader in Amsterdam to steer end-to-end regulatory plans for high-complexity cell therapy programs. You will guide programs from discovery through licensure, coordinating with Global Product Teams to ensure robust evidence, labeling, and compliance.

This role demands leadership across regions and strong engagement with health authorities.

Competenze

• Bachelor's degree in a science-related field.
• 7+ years of regulatory experience.
• Proven cell therapy regulatory strategy success.
• Deep knowledge of global regulatory science and program strategy.
• Extensive experience with drug/biologic development processes.
• Experience in oncology, autoimmune, or rare diseases.
• Leadership of regulatory and cross-functional teams.

Mansioni

• Own the end-to-end global regulatory strategy for complex, multi-indication programs; drive efficient routes to approval and aligned labeling.
• Lead regional strategy when applicable, integrating region-specific execution.
• Shape engagement with health authorities; prepare for meetings and expedited designations.
• Direct dossier and labeling planning; own target product labeling strategy and negotiations.
• Represent Regulatory Affairs on Global Product Teams; align regulatory objectives with clinical, CMC, safety and commercial plans.
• Assess emerging data; present risks and mitigations to senior leadership for data-driven decisions.
• Oversee regulatory deliverables and milestones, including probability-of-success assessments and contingency planning.
• Lead Global Regulatory Strategy Team and develop talent across indications/programs.
• Build partnerships with regulatory stakeholders; align with country and regional teams.
• Promote development of regulatory tools and technology; contribute to cross-functional initiatives.
• Maintain accountability for marketed product stewardship and compliance with evolving requirements.

Conoscenze

Regulatory leadership

Health Authority interactions

Strategic thinking

Stakeholder management

Cross-functional collaboration

Oral and written communication

Project management

Formazione

Bachelor's degree in a science related field

Descrizione del lavoro

Available locations:

Barcelona, Spain

Amsterdam, Netherlands

Are you ready to set the global regulatory vision for pioneering cell therapies and turn breakthrough science into real options for patients? This role leads high-impact programs across cancer, immune-mediated and rare diseases, guiding them from current stage through licensure with clear, competitive pathways to approval and labeling. You will shape strategy for complex, visible programs, bringing clarity, pace and rigor that accelerate access for patients.

You will report to the Executive Director, Cell Therapy Regulatory Affairs and act as a franchise global regulatory lead for programs with multiple indications, with the opportunity to serve in a dual capacity as a regional lead based on your expertise. Working across discovery through commercialization, you will partner closely with Global Product Teams to align science, evidence and policy, while coaching a Global Regulatory Strategy Team to deliver at the highest level.

Could you be the strategic voice that anticipates risk, seizes expedited opportunities and influences the dialogue with global health authorities?

Global Regulatory Leadership

Own the end-to-end global regulatory strategy for a high-complexity cell therapy program, from current stage through BLA submission, ensuring an efficient route to approval with competitive labeling aligned to product attributes and patient, market and business needs. -

Franchise and Regional Responsibility:

Serve as global regulatory lead for complex, multi-indication programs and, where relevant, take on regional leadership to integrate region-specific strategy and execution.

Health Authority Strategy and Engagement:

Lead strategy for agency meetings, information requests and expedited pathway designations; drive robust preparation that secures clear outcomes and de-risks pivotal milestones.

Dossier and Labeling Excellence:

Direct the planning and construction of the global dossier and core prescribing information; own target product labeling strategy and negotiation readiness.

Cross-Functional Product Leadership:

Represent Regulatory Affairs on Global Product Teams, shaping development and commercialization plans, contributing to governance presentations and aligning regulatory objectives with clinical, CMC, safety and commercial strategies.

Evidence and Decision-Making:

Continuously assess emerging data against program aspirations; present risks, trade-offs and mitigations to senior leadership to enable decisive, data-driven choices.

Delivery and Milestone Management:

Oversee all regulatory deliverables and milestones, including probability-of-success assessments and contingency planning to protect timelines and value.

Team Leadership and Talent Development:

Lead a Global Regulatory Strategy Team for specific indications/programs; coach, mentor and, as applicable, line-manage team members to build capability and performance.

External Influence and Partnerships:

Build strong relationships with regulatory stakeholders; partner with country and regional regulatory teams to shape developing views and guidance.

Innovation and Tools:

Lead and promote the development of novel regulatory tools and technology, and contribute to non-project initiatives that advance how we work and the impact we deliver.

Marketed Product Stewardship:

Maintain accountability for product maintenance and compliance activities associated with marketed brands, ensuring continued benefit to patients and compliance with evolving requirements.

Essential Skills/Experience:

• A bachelors degree in a science related field
• 7+ years of experience in the regulatory space
• Demonstrated success in cell therapy regulatory strategy.
• Deep understanding of global regulatory science and integration with program strategy.
• Long standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs.
• Experience with product development in the following therapeutic areas: oncology, autoimmune, rare diseases, neurology.
• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
• Proven experience leading regulatory and cross-functional teams, and stakeholder management.
• Ability to think strategically and critically and evaluate risks to regulatory activities.
• Previous experience in leading Health Authority interactions 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.
• Successful leadership of at least one global regulatory approval including leading response team and labeling negotiations

Desirable Skills/Experience:

• Experience with FDA advisory committee and/or EMA oral explanation. - Experience working on due diligence activities and in a business alliance environment.
• Experience in leading and growing people through coaching or mentorship.
• Contribution to non-project business initiatives (e.g. at a portfolio or cross functional level).

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, your regulatory leadership turns cutting-edge cell therapy science into treatments that change lives—fast.

You will work in a collaborative, empowered environment that blends scientific ambition with practical execution, where unexpected teams come together to challenge assumptions, share knowledge across borders and adopt new technology to shorten development cycles. We value kindness alongside ambition, give you the autonomy to lead and the support to grow, and connect your individual impact directly to patients who are waiting.

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.

26-Nov-2026