Senior Regulatory Affairs Director - Oncology

AstraZeneca

Base: $211,581.60 - $317,372.40; bonus/equity: sho...
Hybrid (3 days in the office)
Global regulatory strategy leadership
Oncology drug development experience
Major regulatory approval track record
AstraZeneca is seeking a Senior Regulatory Affairs Director in Oncology to lead global regulatory strategy and ensure efficient delivery of complex oncology programs. The ideal candidate will have extensive regulatory experience, particularly with drug approvals, and will thrive in a collaborative and innovative environment. ###

Job Summary

  • The Senior Regulatory Affairs Director serves as the Global Regulatory Lead developing strategies for complex oncology programs with multiple indications.
  • Candidates must demonstrate proven leadership in securing major global regulatory approvals and managing labeling negotiations.
  • The role offers a competitive salary ranging from $211,581.60 to $317,372.40 along with equity incentives and comprehensive health benefits.

Matching Summary

Match Score: 85

AstraZeneca is seeking a Senior Regulatory Affairs Director in Oncology to lead global regulatory strategy and ensure efficient delivery of complex oncology programs. The ideal candidate will have extensive regulatory experience, particularly with drug approvals, and will thrive in a collaborative and innovative environment. ###

Salary

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

Skills & Requirements

Must-have

  • Global regulatory strategy leadership
  • Oncology drug development experience
  • Major regulatory approval track record
  • Health authority interaction management
  • Strategic risk assessment capabilities

Nice-to-have

  • Radio-conjugate development knowledge
  • FDA advisory committee experience
  • EMA oral explanation hearing experience
  • Business alliance due diligence background
  • Novel regulatory tool development

Key Requirements

  • Advanced degree in science field
  • Proven leadership of global regulatory teams
  • Experience with small molecules and biologics
  • Deep understanding of global regulatory science

Work Rights

Not specified

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