Director, Regulatory Strategy

Role: Lead global regulatory strategy with a focus on US pre- and post-approval activities for biopharma products. Responsibilities: provide regulatory leadership on project teams, develop strategic plans, oversee submissions including INDs, CTAs, NDAs, and MAAs, interpret regulatory feedback, and guide cross-functional collaboration. Also involved in business development, regulatory policy development, and industry engagement. Requirements: at least 10 years of regulatory affairs experience, advanced degree (MS, PhD, PharmD), strong knowledge of US FDA and international regulations, excellent communication, leadership, and project management skills. High-Value: regulatory leadership in drug development, US FDA and global regulatory expertise, IND/CTA/NDA/MAA submission oversight, strategic planning, post-approval activities, cross-functional collaboration. WorkSetup: hybrid Irvine; some travel (~10%).