Associate Director, Global Regulatory Strategy - International

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

Requirements

• Support the development and execution of global regulatory strategies for products in Olema’s pipeline
• Represent Regulatory Affairs on cross-functional teams and lead the planning and preparation of clinical trial submissions
• Prepare and coordinate high-quality regulatory global submissions, including INDs, CTAs, amendments, annual reports, DSURs, Investigator Brochures, and briefing documents
• Monitor the global regulatory landscape to identify requirements, trends, and potential impact on Olema’s development programs

Benefits

• Competitive compensation and benefits package
• Equity, bonus, and benefits
• Flexible and friendly work environment