Senior Regulatory Affairs Director - Oncology Cell & Gene Therapy

AstraZeneca

Base: $218,058.40 - $327,087.60; bonus/equity: sho...
Cell and gene therapy regulatory strategy
Multiple myeloma disease area expertise
Global regulatory approval leadership
The role leads the global regulatory strategy for complex cell and gene therapy products in oncology, ensuring efficient approval with competitive labeling

Job Summary

  • The role leads the global regulatory strategy for complex cell and gene therapy products in oncology, ensuring efficient approval with competitive labeling.
  • Candidates must possess deep knowledge of multiple myeloma and extensive experience leading major Health Authority interactions including BLA submissions.
  • The position offers a competitive salary ranging from $218,058.40 to $327,087.60 along with comprehensive benefits including equity incentives and retirement plans.

Matching Summary

The role leads the global regulatory strategy for complex cell and gene therapy products in oncology, ensuring efficient approval with competitive labeling.

Salary

Base: $218,058.40 - $327,087.60; Bonus/Equity: Short-term incentive bonus and long-term equity program available; Benefits: 401(k), paid vacation, health/dental/vision coverage

Skills & Requirements

Must-have

  • Cell and gene therapy regulatory strategy
  • Multiple myeloma disease area expertise
  • Global regulatory approval leadership
  • BLA submission and health authority meetings
  • Cross-functional team leadership

Nice-to-have

  • FDA advisory committee experience
  • EMA oral explanation experience
  • Autoimmune condition product development
  • Business alliance due diligence
  • Novel regulatory tool development

Key Requirements

  • Advanced degree in science related field
  • Seven-ten years of relevant experience
  • Proven success in CGT regulatory strategy
  • Experience with multiple myeloma product development
  • Leadership of global regulatory approval processes

Work Rights

Not specified

Tailored Resume

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