Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

Olema Oncology
San Francisco, MA
Category Legal
Job Description
Olema Oncology is seeking a Senior Director of Regulatory Strategy to lead the development and execution of regulatory strategies supporting their oncology products, including palazestrant (OP-1250). The role involves developing NDA submissions, representing the company at regulatory agencies, and providing guidance to global project teams. It requires approximately 20% domestic and international travel.

Requirements

  • Lead the development and execution of regulatory strategies
  • Represent Regulatory Affairs on cross-functional teams
  • Provide regulatory guidance and oversight to global projects
  • Stay abreast of regulatory landscape
  • Ensure regulatory activities are robust and compliant
  • Coordinate and maintain regulatory reports

Benefits

  • Competitive compensation
  • Equity
  • Bonus
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