Director, Regulatory Affairs Strategy Cell Therapy

Job Title: Director Regulatory Affairs Strategy - Cell Therapy

Available locations:

• Barcelona Spain
• Amsterdam Netherlands

Introduction to role:

Are you ready to steer global regulatory strategy for cell therapies that redefine standards of care for patients

In this Director role you will shape the regulatory path for programs that span oncology immune-mediated and rare diseasestranslating breakthrough science into timely approvals and competitive labeling that make a tangible difference to patients and markets.

You will join a high-performing cross-functional environment where regulatory insight is central to program decision-making. Partnering with senior leaders and global teams you will lead strategy across key milestonesfrom expedited designations and Health Authority interactions through major submissions and post-approval maintenancehelping the business deliver transformative therapies at pace and with rigor.

Can you see yourself guiding a complex program from pivotal data through approval and beyond while keeping patient value and global needs front and center

Accountabilities:

Global Regulatory Strategy: Contribute to and implement the global regulatory strategy for a complex CGT product or indication from current stage through key submission milestones; support product maintenance activities as needed.

Program Leadership: Serve as regulatory lead for a product indication or defined program component; may serve in a dual role as Global Regulatory Lead and regional regulatory lead.

Approval Path and Labeling: Ensure regulatory strategies enable an efficient path to approval with competitive labeling aligned to product characteristics and business market and patient needs; contribute to governance presentations.

Health Authority Engagements: Drive strategy and execution for Health Authority meetings responses to information requests expedited pathway designations and BLA development and submission.

Data-Driven Decision-Making: Maintain strong disease area knowledge; lead objective assessments of emerging data versus program aspirations; communicate risks and mitigation plans to senior management.

Milestone Delivery: Support delivery of all project-related regulatory milestones including probability-of-success assessments and mitigation strategies.

Core Documents and Labeling: Lead preparation of regulatory strategy documents and target product labeling; support planning and assembly of the global dossier and core prescribing information with the respective teams.

Cross-Functional Collaboration: Operate as a core member of the Global Product Team and Global Regulatory Strategy Team demonstrating strong strategic communication and collaboration skills to advance development objectives.

Process Excellence: Participate in non-project initiatives to enhance regulatory processes tools and practices; foster knowledge sharing across locations and therapy areas.

Country and Regional Alignment: Partner with country organizations and regional regulatory colleagues to align on evolving views local considerations and regulatory guidance.

Team Development: Provide mentoring and matrix support to less experienced colleagues; may have limited line management responsibilities.

Essential Skills/Experience

• An advanced degree in a science related field and typically five to eight years of experience and/or appropriate knowledge/experience.
• 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.
• 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.

Desirable Skills/Experience:

• Experience in cell therapy regulatory strategy or related regulatory activities.
• Experience with product development in the following therapeutic areas: oncology autoimmune rare diseases neurology.
• Experience supporting a global regulatory approval or major submission activity.
• Experience with FDA advisory committee or EMA oral explanation preparation.
• Experience working on due diligence activities or in a business alliance environment.
• Experience mentoring colleagues or contributing to team development. - Contribution to non-project business initiatives or cross-functional improvement activities.

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions.

Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 regulatory leaders help transform pioneering science into therapies that reach patients fasterby driving innovative approaches smart risk-taking and disciplined execution. You will work across a rich pipeline with colleagues who value curiosity and kindness alongside ambition bringing unexpected teams together to unlock knowledge and sharpen strategy.

Our globally connected community blends cutting-edge technology with deep disease expertise embraces data and automation to reduce cycle times and thrives on collaboration that turns complex challenges into concrete outcomes for patients. Your ideas will be heard your growth supported and your impact visible in every milestone we achieve.

Call to Action: Step into a role where your regulatory leadership accelerates life-changing therapiesseize this opportunity to shape strategy deliver approvals and grow your influence today.

Date Posted

Closing Date

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.