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🥝 Regulatory CMC Director (Cell & Gene Therapy)

AstraZeneca | Gaithersburg, United States | Posted June 19, 2026

Job Description

Are you ready to steer global CMC strategy for cell and gene therapies that redefine what’s possible for patients? This role positions you at the center of breakthrough programs, where your regulatory leadership translates pioneering science into high-quality submissions and decisive health authority interactions that accelerate access for people who need it most.

Based in Santa Monica, CA or Gaithersburg, MD, you will shape end-to-end CMC regulatory pathways across development stages, partnering closely with technical, clinical, and quality leaders. How will you apply your expertise to anticipate risk, set clear direction, and drive rapid, global approvals for a growing pipeline?

Accountabilities:

  • Global CMC Strategy: Provide strategic guidance during all stages of product development and lead the development and implementation of global CMC regulatory strategies for cell and gene therapy programs, enabling efficient approvals and risk-mitigated plans.
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