Director-level regulatory affairs position overseeing global strategy for cell therapy programs across oncology, immunology, and rare diseases. The role involves leading regulatory pathways from data through approval, managing Health Authority interactions, and guiding cross-functional teams to deliver transformative therapies efficiently.
Responsibilities
- Develop and implement integral regulatory strategy for cell therapy products through submission milestones
- Serve as primary regulatory lead for assigned products or program components
- Drive Health Authority engagements, expedited pathway applications, and biologics license submissions
- Lead preparation of regulatory strategy documents, target product labeling, and dossier development




- Provide mentoring and matrix support to junior colleagues; support team development initiatives

Requirements
- Advanced degree in science field with 5-8 years of relevant experience
- Demonstrated expertise in global regulatory science and program strategy integration
- Extensive background in drug/biologic development and complex novel programs
- Proven leadership of regulatory teams and stakeholder management across functions
- Track record leading Health Authority interactions in major markets
- Strong strategic and critical thinking with risk assessment capabilities
- Excellent written, oral, and presentation communication skills

📌 Director, Regulatory Affairs Strategy (España)
🏢 AstraZeneca
📍 España