Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

Olema Oncology

Boston, MA, United States
Base: $275,000-$290,000; bonus/equity: equity, bon...
On-site
Develop innovative regulatory strategies
Lead nda development and submission
Represent regulatory affairs on cross-functional teams
Lead the development and execution of innovative regulatory strategies supporting Olema products

Job Summary

  • Lead the development and execution of innovative regulatory strategies supporting Olema products.
  • Represent Regulatory Affairs on cross-functional teams as the subject matter expert and provide regulatory guidance and oversight to the global project teams, Study Execution Teams, and the Executive Committee.
  • The base pay range for this position is expected to be $275,000-$290,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience.

Matching Summary

Lead the development and execution of innovative regulatory strategies supporting Olema products.

Salary

Base: $275,000-$290,000; Bonus/Equity: equity, bonus; Benefits: benefits

Skills & Requirements

Must-have

  • Develop innovative regulatory strategies
  • Lead NDA development and submission
  • Represent Regulatory Affairs on cross-functional teams
  • Provide regulatory guidance and oversight
  • Lead agency interactions with Global Health Authorities

Nice-to-have

  • Develop department policies and SOPs
  • Mentor and develop regulatory colleagues
  • Adapt to changing business needs

Key Requirements

  • 12 years' experience in Regulatory Affairs
  • 3 years direct leadership experience
  • Experience with major regulatory submissions (NDA/NDS/MAA)
  • Bachelor's degree in a scientific discipline
  • Experience in Oncology Therapeutic area preferred

Work Rights

Not specified

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