Director, International Regulatory Strategy – Cell Therapy

AstraZeneca plc; Cambourne; On-site; GBP 150,000 - 210,000; Full time

Job summary

AstraZeneca plc is seeking a Senior International Regulatory Affairs Director to oversee international strategy for cutting-edge cell therapy programs in Cambridge, UK. You will lead cross-functional teams to shape evidence generation, submissions and labeling for priority markets.

You will drive global regulatory plans from development through lifecycle management, engaging health authorities and senior leaders to secure timely approvals and durable market access.

Qualifications

• Advanced degree in science or regulatory discipline.
• Strong international regulatory experience with senior-level accountability in cell therapy or biologics.
• Demonstrated success in regulatory strategy for high-profile, complex programs.

Responsibilities

• Own the International regulatory strategy for complex cell therapy programs and embed regional needs in global plans.
• Lead end-to-end international strategy from development through major submissions, approvals, launches and lifecycle management.
• Direct international dossier planning, labeling and negotiation readiness for timely submissions.
• Collaborate with clinical, CMC, safety, quality, and commercial teams to align on evidence generation and regulatory decisions.
• Lead health authority engagements and advisory preparations for timely, risk-aware decisions.

Skills

Strategic regulatory leadership

International regulatory strategy

Cross-functional leadership

Regulatory submissions

Education

Advanced degree in science or regulatory

Job description

AstraZeneca plc is seeking a Senior International Regulatory Affairs Director to oversee international strategy for cutting-edge cell therapy programs in Cambridge, UK. You will lead cross-functional teams to shape evidence generation, submissions and labeling for priority markets.

You will drive global regulatory plans from development through lifecycle management, engaging health authorities and senior leaders to secure timely approvals and durable market access.