Director, Regulatory Strategy – Cell Therapy (Global)

AstraZeneca GmbH; Gaithersburg (MD); On-site; USD 186,232 - 279,349; Full time

Job summary

AstraZeneca is seeking a Director of Regulatory Affairs Strategy for cell therapy in the United States. The role focuses on shaping global regulatory strategy for CGT programs spanning oncology and immune-mediated diseases, translating breakthrough science into timely approvals and competitive labeling.

You will lead cross-functional teams, partner with senior leaders, and manage Health Authority interactions from expedited designations to major submissions, ensuring patient value and global

Qualifications

• Advanced degree in science with 5–8 years of experience in regulatory affairs or related field.
• Global regulatory science knowledge and integration with program strategy.
• Experience leading regulatory and cross-functional teams and stakeholder management.

Responsibilities

• Contribute to and implement global regulatory strategy from current stage through key milestones.
• Serve as regulatory lead for a product, indication, or program component.
• Ensure path to approval with competitive labeling aligned to product characteristics.
• Drive strategy and execution for Health Authority meetings and submissions.
• Lead data-driven decision making and Risk mitigation planning.
• Support delivery of regulatory milestones and preparation of core labeling.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory affairs

Health Authority interactions

Strategic thinking

Presentation skills

Education

Advanced science degree

Job description

AstraZeneca is seeking a Director of Regulatory Affairs Strategy for cell therapy in the United States. The role focuses on shaping global regulatory strategy for CGT programs spanning oncology and immune-mediated diseases, translating breakthrough science into timely approvals and competitive labeling.

You will lead cross-functional teams, partner with senior leaders, and manage Health Authority interactions from expedited designations to major submissions, ensuring patient value and global