Senior Regulatory Affairs Director - Oncology

AstraZeneca

Base: $211,581.60 - $317,372.40; bonus/equity: sho...
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Global regulatory strategy leadership
Oncology drug development experience
Major health authority interaction management
** AstraZeneca is seeking a Senior Regulatory Affairs Director for their Oncology division to lead global regulatory strategies for complex oncology programs. The ideal candidate will have extensive experience in regulatory drug development, particularly in oncology, and possess strong leadership skills to navigate regulatory challenges and ensure timely product approvals. **

Job Summary

  • The Senior Regulatory Affairs Director serves as the Franchise Global Regulatory Lead developing strategies for complex oncology programs with multiple indications.
  • Candidates must demonstrate proven leadership in delivering major regulatory approvals at a global level including leading response teams and labeling negotiations.
  • AstraZeneca offers a competitive salary ranging from $211,581.60 to $317,372.40 along with short-term incentives, equity-based long-term programs, and comprehensive health benefits.

Matching Summary

Match Score: 75

** AstraZeneca is seeking a Senior Regulatory Affairs Director for their Oncology division to lead global regulatory strategies for complex oncology programs. The ideal candidate will have extensive experience in regulatory drug development, particularly in oncology, and possess strong leadership skills to navigate regulatory challenges and ensure timely product approvals. **

Salary

Base: $211,581.60 - $317,372.40; Bonus/Equity: Short-term incentive bonus and equity-based long-term incentive program available; Benefits: Qualified retirement program (401k), paid vacation, holidays, leaves, medical, dental, vision coverage

Skills & Requirements

Must-have

  • Global Regulatory Strategy leadership
  • Oncology drug development experience
  • Major health authority interaction management
  • Regulatory approval and launch delivery
  • Strategic risk assessment and mitigation

Nice-to-have

  • Radio-conjugates development experience
  • FDA advisory committee experience
  • EMA oral explanation hearing experience
  • Due diligence and business alliance background
  • Novel regulatory tools and technology development

Key Requirements

  • Advanced degree in science related field
  • Proven leadership experience in pharmaceutical business
  • Deep understanding of global regulatory science
  • Experience with small molecules and biologics

Work Rights

Not specified

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