Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs
Olema OncologyBoston, Massachusetts, United States • San Francisco, California, United States
Posted September 18, 2025
275000 - 290000 USD year
Full Time
About the Company
Olema Oncology is a cancer medicines company focused on developing innovative treatments for breast cancer and other malignancies. Led by palazestrant (OP-1250), a complete estrogen receptor antagonist, and OP-3136, a KAT6 pathway inhibitor, the company aims to create more effective therapies that improve patient outcomes. Olema's team is dedicated to its mission of developing better medicines with clarity and intention.
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
