Director, Regulatory Affairs Strategy - Cell Therapy

About the role

AstraZeneca is looking for a Director, Regulatory Affairs Strategy for cell therapy, based in Barcelona, Spain or Amsterdam, Netherlands. The role shapes the regulatory path for programs spanning oncology, immune-mediated and rare diseases, partnering with senior leaders and global teams to guide complex programs from pivotal data through approval and beyond.

Key responsibilities

• Contribute to and implement the global regulatory strategy for a complex cell gene therapy (CGT) product or indication, from current stage through key submission milestones, and support product maintenance.
• Serve as regulatory lead for a product, indication or program component, possibly in a dual role as Global Regulatory Lead and regional regulatory lead.
• Ensure an efficient path to approval with competitive labeling aligned to product, market and patient needs, and contribute to governance presentations.
• Drive Health Authority meetings, responses to information requests, expedited pathway designations, and BLA development and submission.
• Maintain strong disease area knowledge, assess emerging data against program aspirations, and communicate risks and mitigation plans to senior management.
• Support milestone delivery, including probability-of-success assessments and mitigation strategies.
• Lead preparation of regulatory strategy documents and target product labeling, and support the global dossier and core prescribing information.
• Work as a core member of the Global Product Team and Global Regulatory Strategy Team, and partner with country organizations and regional colleagues.
• Mentor less experienced colleagues and take part in non-project initiatives to improve regulatory processes and tools.

Required profile

• Advanced degree in a science-related field and typically five to eight years of experience and/or appropriate knowledge.
• Long-standing experience of drug and biologic development processes for high-profile, complex or novel programs.
• Broad background in pharmaceutical business and regulatory affairs, with proven experience leading regulatory and cross-functional teams and managing stakeholders.
• Previous experience leading Health Authority interactions in major markets.
• Desirable: experience in cell therapy regulatory strategy, oncology, autoimmune, rare diseases or neurology, global approval or major submission support, FDA advisory committee or EMA oral explanation preparation, due diligence or business alliance work, and mentoring.

Required skills

• Strategic and critical thinking, with the ability to evaluate risks to regulatory activities.
• Excellent oral, written and presentation skills, and strong organizational skills.
• Ability to work hands-on in a fast-paced environment and manage multiple projects.

The company works on average at least three days per week from the office, balancing presence with individual flexibility. It welcomes applications from all qualified candidates and complies with applicable non-discrimination and employment eligibility requirements.