Sr Director, Regulatory Affairs Strategy

Role: Senior Director of Regulatory Affairs Strategy, leading global regulatory development and lifecycle management for biopharma assets. Responsibilities: provide strategic and tactical regulatory guidance across all development phases, oversee major submissions (US and international), manage lifecycle changes, and influence regulatory pathways to ensure timely approvals and compliance. Collaborate with cross-functional teams, represent the company in global health authority interactions, and lead regulatory intelligence and influence strategies. Requirements: 15+ years in regulatory affairs with a scientific degree (MS, Ph.D., PharmD); deep expertise in US FDA and international regulations, drug development processes, and GxP standards. HighValue: experience in complex asset strategies, global submissions, and post-approval lifecycle management; strong leadership, negotiation, and decision-making skills; ability to operate in fast-paced, entrepreneurial environments. WorkSetup: based in Irvine with hybrid remote options; travel up to 20%.