Senior Regulatory Affairs Director - Oncology

AstraZeneca

Base: $211,581.60 - $317,372.40; bonus/equity: sho...
Hybrid (3 days in the office, 2 days remote)
Global regulatory strategy leadership
Oncology drug development experience
Leading major health authority interactions
AstraZeneca is seeking a Senior Regulatory Affairs Director for its Oncology division, responsible for leading global regulatory strategies and ensuring the successful approval of oncology products. The ideal candidate will have extensive experience in regulatory drug development and proven leadership in obtaining major regulatory approvals

Job Summary

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

Matching Summary

Match Score: 85

AstraZeneca is seeking a Senior Regulatory Affairs Director for its Oncology division, responsible for leading global regulatory strategies and ensuring the successful approval of oncology products. The ideal candidate will have extensive experience in regulatory drug development and proven leadership in obtaining major regulatory 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
  • Leading major health authority interactions
  • Strategic risk assessment and mitigation
  • Advanced degree in science field

Nice-to-have

  • Experience with radio-conjugates development
  • FDA advisory committee interaction experience
  • EMA oral explanation hearing experience
  • Business alliance and due diligence background
  • Novel regulatory tools and technology development

Key Requirements

  • Advanced degree in science related field
  • Previous demonstrated experience of regulatory drug development
  • Solid knowledge of regulatory affairs in early and late development
  • Proven leadership experience in pharmaceutical business
  • Long standing experience in overall drug/biologic development processes

Work Rights

Not specified

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