Global Cell Therapy Regulatory Strategy Director

AstraZeneca; San Francisco (CA); Hybrid; USD 276,000 - 414,000; Full time

Job summary

AstraZeneca in the United States is seeking an Executive Director to set the global regulatory direction for first-in-class cell therapies. This senior leader will steer strategy from discovery through global submissions, shape labeling and lifecycle planning, and engage health authorities to secure timely approvals across indications and modalities.

You will lead regulatory teams, influence governance, and partner with regional teams to accelerate patient access while building organizational

Qualifications

• Bachelor degree in a science-related field; 10+ years of regulatory experience.
• Demonstrated extensive success in cell therapy regulatory strategy.
• Deep understanding of global regulatory science and integration with program strategy.
• Experience leading regulatory teams and influencing senior stakeholders.
• Experience with Health Authority interactions in major markets.

Responsibilities

• Own end-to-end global regulatory strategy for a cell therapy product or franchise.
• Lead engagement with health authorities and design expedited pathways.
• Coach and develop regulatory talent across teams; manage multiple programs.
• Ensure milestones, labeling, and dossier quality for rapid approvals and lifecycle management.

Skills

Regulatory strategy

Leadership

Global regulatory

Communication

Strategic thinking

Cross-functional collaboration

Due diligence

Education

Bachelor degree in science

Master's Degree/PhD/MD in science

Job description

AstraZeneca in the United States is seeking an Executive Director to set the global regulatory direction for first-in-class cell therapies. This senior leader will steer strategy from discovery through global submissions, shape labeling and lifecycle planning, and engage health authorities to secure timely approvals across indications and modalities.

You will lead regulatory teams, influence governance, and partner with regional teams to accelerate patient access while building organizational