Overview

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 integral 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 global dossier assembly Collaborate as a core member of Global Product Team and General 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 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