Director, Regulatory Affairs

Kuraoncology

Boston, United States
Base: $226,495 - $258,817 py; bonus/equity: annual...
On-site
Us and global regulatory strategies
Ind/cta, nda/maa submissions
Regulatory agency communications
Develop, implement, and provide guidance on US and global regulatory strategies to support the development of Kura’s oncology and hematology portfolio

Job Summary

  • Develop, implement, and provide guidance on US and global regulatory strategies to support the development of Kura’s oncology and hematology portfolio.
  • Lead and oversee the preparation, submission, approval, and maintenance of regulatory applications, and manage regulatory agency communications.
  • Advise cross-functional development teams on regulatory requirements, pathways, and risks, ensuring compliance with relevant laws and guidances.

Matching Summary

Develop, implement, and provide guidance on US and global 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, equity, generous stock options; Benefits: Generous benefits package, 401K + Employer contributions, ESPP Plan, PTO, Holidays, Paid Paternity/Maternity Leave, Lifestyle Spending Stipend, Commuter Stipend

Skills & Requirements

Must-have

  • US and global regulatory strategies
  • IND/CTA, NDA/MAA submissions
  • Regulatory agency communications
  • Drug development process knowledge
  • FDA and/or other agency interaction

Nice-to-have

  • Values-driven work style
  • Patient-focused mindset
  • Roll-up-your-sleeves attitude
  • Hematology/Oncology experience

Key Requirements

  • 10+ years pharmaceutical/biotechnology industry experience
  • 5+ years regulatory experience
  • Bachelors degree in life science (PharmD/MS preferred)
  • Experience supporting NDAs and post-approval products
  • Experience leading IND/CTA submissions
  • Experience working with FDA and/or other agencies
  • US and EU regulatory landscape understanding

Work Rights

Not specified

Tailored Resume

Cover Letter