Regulatory Affairs Director - Oncology

AstraZeneca

Base: $186,232.80 - $279,349.20; bonus/equity: sho...
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Lead cross functional regulatory teams
Develop global regulatory strategy
Manage major regulatory submissions
** AstraZeneca is seeking a Regulatory Affairs Director specializing in Oncology to lead strategic regulatory initiatives and cross-functional teams to ensure efficient approval of oncology products. The ideal candidate will possess strong regulatory strategy experience, particularly in oncology, and will play a crucial role in engaging with health authorities and developing regulatory strategies. **

Job Summary

  • The Regulatory Affairs Director provides strategic leadership for the development, commercialization, and life cycle management of oncology products.
  • Candidates will lead cross-functional teams in major regulatory submissions including NDA, BLA, IND, and CTA while managing health authority interactions.
  • The role offers a competitive salary ranging from $186,232.80 to $279,349.20 along with comprehensive benefits including 401(k) and health coverage.

Matching Summary

Match Score: 75

** AstraZeneca is seeking a Regulatory Affairs Director specializing in Oncology to lead strategic regulatory initiatives and cross-functional teams to ensure efficient approval of oncology products. The ideal candidate will possess strong regulatory strategy experience, particularly in oncology, and will play a crucial role in engaging with health authorities and developing regulatory strategies. **

Salary

Base: $186,232.80 - $279,349.20; 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

Skills & Requirements

Must-have

  • Lead cross functional regulatory teams
  • Develop global regulatory strategy
  • Manage major regulatory submissions
  • Conduct health authority interactions
  • Oversee label negotiations

Nice-to-have

  • Strategic thinking and influencing skills
  • Experience with phase 3 design
  • Knowledge of benefit risk profiles
  • Innovation and initiative in RA
  • Global pipeline experience

Key Requirements

  • Bachelor's degree in science related field
  • At least 3 years of Regulatory strategy experience
  • Solid knowledge of regulatory affairs in early and late development
  • Previous demonstrated experience with major HA interactions
  • Experience in Oncology therapeutic area preferred

Work Rights

Not specified

Tailored Resume

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