Associate Director, Global Regulatory Strategy - International

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. The company is looking for an Associate Director, Global Regulatory Strategy - International to contribute to the development and execution of regulatory strategies for their products in early to late-stage clinical development.

Requirements

• Bachelor’s degree in a scientific discipline required; advanced degree (MS, PharmD, PhD) preferred
• Minimum 10 years of related experience with a Bachelor’s degree; or 7 years and a Master’s degree; or a PhD with 5 years experience; 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 and benefits package
• Flexible and open work environment
• Opportunity for career development and growth