Associate Director, Global Regulatory Affairs Compliance

Role: Associate Director, Global Regulatory Affairs Compliance, supporting Olema's clinical development programs with a focus on breast cancer therapies. Responsibilities include developing and implementing regulatory strategies, ensuring compliance across submissions such as INDs, NDAs, and regulatory communications, and supporting regulatory and quality inspections. The role involves translating laws and guidance into practical compliance measures, reviewing regulatory documents for accuracy, and enhancing policies and procedures. Requirements: Bachelor's degree in a scientific discipline (advanced degree preferred), 8+ years of regulatory affairs experience in pharma/biotech, strong technical and regulatory writing skills, and proven ability to interpret complex regulations. High-Value: Focus on oncology (breast cancer), biologics and small molecules, primarily in Phase 3 development, supporting global filings, and working closely with cross-functional teams. Work Setup: Hybrid in Cambridge, MA or San Francisco, CA; approximately 10% travel.