Associate Director, Global Regulatory Affairs Compliance

Role: Associate Director, Global Regulatory Affairs Compliance, supporting Olema's oncology development programs. Responsibilities: develop and execute regulatory strategies ensuring compliance across submissions—INDs, NDAs, and GxP documentation; review and author submission documents; maintain regulatory policies and prepare for inspections. Requirements: Bachelor's degree (advanced preferred), 8+ years in pharmaceutical or biotech regulatory affairs; strong technical and regulatory writing skills; proven ability to interpret laws, guide compliance, and collaborate cross-functionally. High-Value: focus on oncology, biologics, or small molecules; experience with regulatory submissions and lifecycle management; knowledge of FDA regulations (21 CFR parts, ICH guidelines); global compliance experience preferred. Work Setup: based in Cambridge, MA or San Francisco, CA; hybrid with at least two days onsite; 10% travel expected.