Regulatory Affairs Director - Oncology

AstraZeneca

Base: $186,232.80 - $279,349.20; bonus/equity: sho...
Lead cross functional teams in major regulatory submissions
Develop global regulatory strategy for oncology products
Manage health authority interactions and briefing documents
The Regulatory Affairs Director provides strategic leadership to bring life-changing oncology medicines to patients efficiently

Job Summary

  • The Regulatory Affairs Director provides strategic leadership to bring life-changing oncology medicines to patients efficiently.
  • The role involves leading cross-functional teams to secure major regulatory approvals including NDA, BLA, IND, and CTA.
  • Competitive salary ranges from $186,232.80 to $279,349.20 with short-term incentives and equity-based long-term programs.

Matching Summary

The Regulatory Affairs Director provides strategic leadership to bring life-changing oncology medicines to patients efficiently.

Salary

Base: $186,232.80 - $279,349.20; Bonus/Equity: Short-term incentive bonus and equity-based long-term incentive program; Benefits: Qualified retirement program, paid vacation, health coverage

Skills & Requirements

Must-have

  • Lead cross functional teams in major regulatory submissions
  • Develop global regulatory strategy for oncology products
  • Manage health authority interactions and briefing documents
  • Own negotiations with health authorities for approvals
  • Prepare global dossier and core prescribing information

Nice-to-have

  • Strategic thinking and risk evaluation skills
  • Experience with phase 3 design and end of phase 2
  • Knowledge of benefit/risk profile and dose selection
  • Ability to work within business critical high-profile programs
  • Broad background in pharmaceutical business operations

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 small molecules and biologics preferred

Work Rights

Not specified

Tailored Resume

Cover Letter