Global Cell Therapy Regulatory Strategy Director

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

Benefits offered by this job

Global exposure

Leadership role

Competitive compensation

Job summary

AstraZeneca plc in the United Kingdom seeks a senior regulatory leader to steer international strategy for complex cell therapies, guiding evidence generation, submission planning and labeling decisions that accelerate access across priority markets.

You will partner with Global Product, Regulatory, Commercial and Medical teams to shape evidence, de-risk milestones and position therapies for long-term success across international markets.

Qualifications

• Advanced degree in a science-related field with regulatory experience.
• Strong international regulatory experience with senior-level accountability.
• Proven leadership of regulatory strategies for high-profile cell therapy programs.
• Extensive knowledge of global regulatory systems and CMC for CGTs/biologics.
• Experience with major submissions (IND/MAA/BLA) and labeling negotiations.

Responsibilities

• Own International regulatory strategy for complex cell therapy programs, embedding regional needs.
• Lead end-to-end regulatory strategy from development to launch and lifecycle management.
• Integrate clinical, CMC, safety, quality, commercial and medical considerations.
• Orchestrate Health Authority engagements and advisory preparations; brief leaders on scenarios.
• Direct International dossier planning and labeling, ensuring on-time high-quality submissions.
• Collaborate with international teams to anticipate market needs and align plans.
• Lead risk assessments and contingency planning to protect timelines and value.
• Coach the International Regulatory Team and promote a culture of empowerment.

Skills

Leadership

Regulatory strategy

Cell therapy

Cross-functional leadership

Stakeholder mgmt

Global regulatory

Education

Advanced science degree

Regulatory affairs experience

Job description

AstraZeneca plc in the United Kingdom seeks a senior regulatory leader to steer international strategy for complex cell therapies, guiding evidence generation, submission planning and labeling decisions that accelerate access across priority markets.

You will partner with Global Product, Regulatory, Commercial and Medical teams to shape evidence, de-risk milestones and position therapies for long-term success across international markets.