Senior Director, Regulatory Affairs

Role: Lead global regulatory strategy and operations for Annexon Biosciences' late-stage neuroinflammatory therapies. Responsibilities: oversee development, registration, and lifecycle management of biologics and small molecules, including INDs, CTAs, BLA/NDAs, and MAA submissions; develop and execute global regulatory plans; manage interactions with FDA, EMA, and other authorities; lead regulatory strategy for milestones like Fast Track and Orphan Drug designations; and mentor regulatory teams. Requirements: PhD/PharmD with 12+ years (PhD) or 14+ years (BS/MS) in Regulatory Affairs; proven success in major marketing applications and regulatory submissions; extensive experience working with FDA and EMA regulations, CTD/eCTD standards, and biologics or small molecules development, especially in rare disease, immunology, or neuroscience. HighValue: biologics/small molecules, late-stage development, global regulatory filings, FDA/EMA engagement, orphan and breakthrough therapies, mixed biotech/pharma industry experience. WorkSetup: hybrid in Brisbane, CA, with regular onsite presence.