Global Regulatory Strategy Director - Cell Therapy

AstraZeneca plc; Cambridge (MA); Hybrid; USD 218,000 - 327,000; Full time

Job summary

AstraZeneca plc is seeking a strategic Regulatory Leader to own the global regulatory vision for high-complexity cell therapy programs, guiding them from development through licensure with efficient paths to approval and labeling.

The role spans discovery to commercialization, partnering with Global Product Teams and coaching a Global Regulatory Strategy Team to deliver results at the highest level.

Qualifications

• Bachelor's degree in a science related field.
• 7+ years of experience in the regulatory space.
• Demonstrated success in cell therapy regulatory strategy.
• Deep understanding of global regulatory science and program strategy.
• Broad experience across drug/biologic development and high-profile programs.
• Experience in oncology, autoimmune, rare diseases, or neurology.
• Proven experience leading regulatory and cross-functional teams.
• Strategic and risk-aware with leadership of Health Authority interactions.
• Excellent oral, written, and presentation skills.
• Strong organizational skills and ability to work in fast-paced environment.
• Flexible and proactive with multi-project management.
• Leadership of at least one global regulatory approval including labeling negotiations.

Responsibilities

• Own end-to-end global regulatory strategy for high-complexity cell therapy programs.
• Lead global/regional regulatory strategy and partner with Global Product Teams.
• Engage Health Authorities to design expedited pathways and robust preparation.

Skills

Regulatory strategy

Global regulatory leadership

Cross-functional leadership

Health Authority interactions

Excellent communication

Education

Bachelor's degree in a science related field

Job description

AstraZeneca plc is seeking a strategic Regulatory Leader to own the global regulatory vision for high-complexity cell therapy programs, guiding them from development through licensure with efficient paths to approval and labeling.

The role spans discovery to commercialization, partnering with Global Product Teams and coaching a Global Regulatory Strategy Team to deliver results at the highest level.