Director, Regulatory Affairs

Kura Oncology

Boston, United States
Base: $226,495 - $258,817 py; bonus/equity: annual...
On-site
10+ years pharmaceutical industry experience
5+ years regulatory experience
Experience leading ind/cta submissions
The Director will develop and implement regulatory strategies to support the development of Kura's oncology and hematology portfolio

Job Summary

  • The Director will develop and implement regulatory strategies to support the development of Kura's oncology and hematology portfolio.
  • Candidates must possess excellent judgment, organizational skills, and exceptional written and verbal communication abilities.
  • The role offers a competitive compensation package including equity, annual target bonus, and generous benefits like paid paternity/maternity leave.

Matching Summary

The Director will develop and implement regulatory strategies to support the development of Kura's oncology and hematology portfolio.

Salary

Base: $226,495 - $258,817 per year; Bonus/Equity: Annual target bonus and generous stock options included; Benefits: Generous benefits package with employer match, 401K, and 20 days PTO

Skills & Requirements

Must-have

  • 10+ years pharmaceutical industry experience
  • 5+ years regulatory experience
  • Experience leading IND/CTA submissions
  • Knowledge of US and EU regulatory landscape
  • Direct interaction with FDA and other agencies

Nice-to-have

  • Hematology or oncology therapeutic area experience
  • Orphan-drug development experience
  • Post-approval product and labeling experience
  • Values-driven collaborative engagement style
  • Ability to influence at various organizational levels

Key Requirements

  • PharmD, MS, or Bachelor's in life science
  • 10+ years pharmaceutical/biotech experience
  • 5+ years specific regulatory experience
  • Solid working knowledge of drug development process

Work Rights

Not specified

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