Senior Manager, Global Regulatory Affairs Strategy

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. As the Senior Manager, Global Regulatory Affairs Strategy, you will provide regulatory strategy support and manage regulatory aspects through all phases of development.

Requirements

• Bachelor's degree in a scientific discipline required; advanced degree (MS, PharmD, PhD) preferred
• Minimum 5 years of regulatory affairs experience in the pharmaceutical or biotechnology industry
• Direct experience preparing and submitting clinical trial applications (INDs, CTAs) and managing regulatory authority correspondence
• Knowledge of global regulatory requirements for clinical development (FDA, EMA, ICH guidelines)
• Oncology therapeutic area experience preferred
• Experience collaborating in cross-functional, matrixed teams
• Experience working with CROs and other partners

Benefits

• Competitive compensation package
• Equity
• Bonus
• Benefits package