Associate Director, Global Regulatory Affairs Compliance

Role: Associate Director, Global Regulatory Affairs Compliance, supporting Olema’s clinical development programs. Responsibilities include translating laws and guidance into regulatory strategies, managing and reviewing high-quality submissions such as INDs, NDAs, and meeting materials, and developing regulatory policies. The role ensures compliance during product lifecycle stages and supports inspections. Requirements: bachelor’s in a scientific discipline, 8+ years in pharmaceutical or biotech regulatory affairs, with expertise in technical/regulatory writing and applying regulatory guidance. Preferred: advanced degree, strong project management, and communication skills. High-value specifics: focus on oncology, with lead therapies in ER+/HER2- metastatic breast cancer, including Phase 3 trials, and ongoing clinical development. The position involves collaboration across functions, with an onsite requirement in Cambridge, MA or San Francisco, CA (at least two days/week) and approximately 10% travel.