Global Regulatory Strategy Director — Cell Therapy

AstraZeneca plc; Amsterdam; On-site; EUR 150,000 - 210,000; Full time

Job summary

AstraZeneca plc is seeking a strategic and hands-on Global Regulatory Leader in Amsterdam to steer end-to-end regulatory plans for high-complexity cell therapy programs. You will guide programs from discovery through licensure, coordinating with Global Product Teams to ensure robust evidence, labeling, and compliance.

This role demands leadership across regions and strong engagement with health authorities.

Qualifications

• Bachelor's degree in a science-related field.
• 7+ years of regulatory experience.
• Proven cell therapy regulatory strategy success.
• Deep knowledge of global regulatory science and program strategy.
• Extensive experience with drug/biologic development processes.
• Experience in oncology, autoimmune, or rare diseases.
• Leadership of regulatory and cross-functional teams.

Responsibilities

• Own the end-to-end global regulatory strategy for complex, multi-indication programs; drive efficient routes to approval and aligned labeling.
• Lead regional strategy when applicable, integrating region-specific execution.
• Shape engagement with health authorities; prepare for meetings and expedited designations.
• Direct dossier and labeling planning; own target product labeling strategy and negotiations.
• Represent Regulatory Affairs on Global Product Teams; align regulatory objectives with clinical, CMC, safety and commercial plans.
• Assess emerging data; present risks and mitigations to senior leadership for data-driven decisions.
• Oversee regulatory deliverables and milestones, including probability-of-success assessments and contingency planning.
• Lead Global Regulatory Strategy Team and develop talent across indications/programs.
• Build partnerships with regulatory stakeholders; align with country and regional teams.
• Promote development of regulatory tools and technology; contribute to cross-functional initiatives.
• Maintain accountability for marketed product stewardship and compliance with evolving requirements.

Skills

Regulatory leadership

Health Authority interactions

Strategic thinking

Stakeholder management

Cross-functional collaboration

Oral and written communication

Project management

Education

Bachelor's degree in a science related field

Job description

AstraZeneca plc is seeking a strategic and hands-on Global Regulatory Leader in Amsterdam to steer end-to-end regulatory plans for high-complexity cell therapy programs. You will guide programs from discovery through licensure, coordinating with Global Product Teams to ensure robust evidence, labeling, and compliance.

This role demands leadership across regions and strong engagement with health authorities.