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About the Role

Lead high-impact global regulatory strategy programs for pioneering cell and gene therapies, guiding them from current stage through licensure with clear, competitive pathways to approval and labeling. Shape strategy for complex, visible programs, bringing clarity, pace, and rigor to accelerate patient access. Report to the Executive Director, Cell and Gene Therapy Regulatory Affairs and act as a franchise global regulatory lead, with the opportunity to serve as a regional lead. Partner closely with Global Product Teams and coach a Global Regulatory Strategy Team.

Responsibilities

Own the end-to-end global regulatory strategy for a high-complexity cell and gene 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.
Serve as global regulatory lead for complex, multi-indication programs and, where relevant, take on regional leadership to integrate region-specific strategy and execution.
Lead strategy for agency meetings, information requests, and expedited pathway designations; drive robust preparation that secures clear outcomes and de-risks pivotal milestones.
Direct the planning and construction of the global dossier and core prescribing information; own target product labeling strategy and negotiation readiness.
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.
Continuously assess emerging data against program aspirations; present risks, trade-offs, and mitigations to senior leadership to enable decisive, data-driven choices.
Oversee all regulatory deliverables and milestones, including probability-of-success assessments and contingency planning to protect timelines and value.
Lead a Global Regulatory Strategy Team for specific indications/programs; coach, mentor, and, as applicable, line-manage team members to build capability and performance.
Build strong relationships with regulatory stakeholders; partner with country and regional regulatory teams to shape developing views and guidance.
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.
Maintain accountability for product maintenance and compliance activities associated with marketed brands, ensuring continued benefit to patients and compliance with evolving requirements.

Requirements

An advanced degree in a science-related field and seven to ten years of experience and/or appropriate knowledge/experience.
Demonstrated success in cell and/or gene 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 oncology, autoimmune, rare diseases, or neurology therapeutic areas.
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, 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.

Skills

Cell and gene therapy regulatory strategy
Global regulatory science
Drug/biologic development processes
Oncology
Autoimmune
Rare diseases
Neurology
Pharmaceutical business
Regulatory affairs
Team leadership
Stakeholder management
Strategic thinking
Critical evaluation
Risk assessment
Health Authority interactions
Oral communication
Written communication
Presentation skills
Organizational skills
Project management
Adaptability
Flexibility
Proactiveness
FDA advisory committee experience
EMA oral explanation experience
Due diligence activities
Business alliance environment experience
People leadership
Coaching
Mentorship
Contribution to non-project business initiatives

Location

Barcelona, Spain
Amsterdam, Netherlands

Work Type

Hybrid

Experience Level

Senior
Seven to ten years of experience

Education Level

Advanced degree in a science-related field

About the Company

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company.
We focus on discovering, developing, and commercializing prescription medicines for some of the world’s most serious diseases.
We are dedicated to being a Great Place to Work where employees are empowered to push boundaries, challenge convention, and unleash their entrepreneurial spirit.
We embrace differences and take bold actions to drive change needed to meet global healthcare and sustainability challenges.
We foster an inclusive culture where diverse thinking generates new and valuable opportunities.
We are committed to lifelong learning, growth, and development for all.
Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients.
Inclusion and diversity are fundamental to our success, as innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking.
We are curious about science and the advancement of knowledge.
We find creative ways to approach new challenges.
We are driven to make the right choices and be accountable for our actions.
As an organization centered around what makes us human, we put a big focus on people.
We want colleagues to wake up excited about their day.
Our promise is to help colleagues realize the full breadth of their potential.
Here, you’ll do work that has the potential to change your life and improve countless others.
Together with your team, you’ll shape a culture that unites and inspires us every day.

Equal Opportunity

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees.
In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics.
If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.