Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs
Olema OncologySan Francisco, California, United States • Boston, Massachusetts, 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 Global Regulatory Strategy to lead the development and execution of regulatory strategies supporting their oncology pipeline. This role involves leading regulatory submissions, providing guidance to cross-functional teams, and ensuring regulatory compliance. The company focuses on developing innovative medicines impacting breast cancer and beyond, with a mission to help patients feel better.
Requirements
- Lead the development and submission of NDAs.
- Develop and execute regulatory strategies supporting the company's product portfolio.
- Represent Regulatory Affairs on cross-functional teams and provide regulatory guidance.
- Maintain regulatory compliance and coordinate reporting schedules.
Benefits
- Competitive compensation
- Equity
- Bonus
- Benefits package
