Director, Regulatory Affairs ~ Strategy, Immunology and Inflammation

Role: Lead global regulatory strategy for immunology and inflammation programs in a clinical-stage biopharma focusing on targeted protein degradation. Responsibilities include developing and executing regulatory strategies for early and late-stage development, preparing global submissions (INDs, CTAs, NDAs, MAAs), and managing interactions with health authorities like FDA and EMA. The role involves cross-functional collaboration with clinical development, CROs, and regulatory teams, along with tracking submission timelines, ensuring compliance, and supporting regulatory systems. Requirements: Bachelor's in life sciences; 12+ years in Regulatory Affairs with extensive immunology and inflammation experience; deep knowledge of FDA, EMA, ICH guidelines; proven success in regulatory filings and interactions; strong project management, communication, and leadership skills. Preferred: advanced degree. High-Value: immunology/inflammation therapeutic area, global regulatory strategy, IND/ NDA/ MAA filings, experience with FDA/EMA, regulatory systems development. WorkSetup: onsite in Brisbane, CA.