Senior Director, Global Regulatory Strategy

Role: Senior Director, Global Regulatory Strategy, leading regulatory activities for Centessa's neurological assets, including orexin receptor agonists for sleep-wake disorders. Responsibilities: develop and execute global regulatory strategies, lead NDA/IND planning and submissions, manage interactions with FDA and international agencies, guide cross-functional teams, oversee external vendors, and mentor regulatory staff. Requirements: Bachelor's in a scientific discipline with 12+ years in pharma/biotech regulatory affairs, including 5+ years in global leadership; advanced degree (PhD, PharmD, MS, JD) preferred; extensive NDA experience, including strategy, submission, and regulatory review; proven track record with FDA, EMA, and other agencies; strong knowledge of drug development, GxP, and global regulatory guidelines. HighValue: biologics/small molecules, sleep-wake disorder indications, late-stage development, NDA submissions, global regulatory interactions, leadership in matrixed organizations, US-based role with occasional travel. WorkSetup: US-based, full-time, with occasional travel.