Overview
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As Director, you will shape global regulatory strategy for cell and gene therapies, driving timely approvals and competitive labeling across oncology, immune-mediated and rare diseases. You’ll partner with senior leaders and cross-functional teams to steer strategy from designation through submissions and post-approval activities. This role combines strategic leadership with hands-on execution to accelerate patient access while maintaining rigorous regulatory standards. You will lead complex programs, translate data into actionable plans, and influence global regulatory decisions that align with the business and patient needs.
Responsabilidades
Contribute to and implement global regulatory strategy for complex CGT programs from current stage to key milestones; support maintenance activities
Act as regulatory lead for a product/indication or program component, potentially in dual Global and regional roles
Design efficient regulatory paths and competitive labeling aligned with product characteristics and market needs
Drive Health Authority engagements, responses to information requests, expedited pathway designations, and BLA development/submission
Lead data-driven risk assessments and communicate mitigation plans to senior management




Support milestone delivery and probability-of-success assessments with mitigation strategies
Lead creation of regulatory strategy documents and target product labeling; assist with integral dossier assembly
Collaborate as a core member of Global Product Team and Global Regulatory Strategy Team to advance development objectives
Participate in process improvements to regulatory tools and practices across locations and therapy areas
Align country and regional regulatory views with evolving guidance; mentor and provide matrix support to colleagues
Requisitos principales
Advanced degree in a science-related field; typically 5–8 years of relevant experience
Understanding of global regulatory science and integration with program strategy
Extensive experience in drug/biologic development xqbhyrx for complex or novel programs
Broad pharma regulatory affairs experience with cross-functional leadership and stakeholder management
Proven ability to lead regulatory and cross-functional teams and manage stakeholders
Strategic and critical thinking with risk assessment for regulatory activities
Experience leading Health Authority interactions in major markets
Excellent communication, presentation, and organizational skills
Ability to thrive in a fast-paced, multi-project environment; flexible and proactive
collaboration
leadership
communication
global regulatory strategy for CGT
Health Authority interactions
BLA development and submission

📌 Director, Regulatory Affairs Strategy - Cell Therapy (Barcelona)
🏢 AstraZeneca
📍 Barcelona