Senior Manager, Global Regulatory Affairs Strategy

Olema Oncology is a biotech company dedicated to developing better medicines for breast cancer and beyond. We're looking for a Senior Manager, Global Regulatory Affairs Strategy to provide regulatory strategy support and manage regulatory aspects through all phases of development.

Requirements

• Bachelor’s degree in a scientific discipline
• 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

Benefits

• Competitive compensation and benefits package
• Equity
• Bonus
• Flexible and friendly work environment