Director, Global Regulatory Strategy

Role: Director, Global Regulatory Strategy leading regulatory planning for monoclonal antibody and biologic-device combination programs in autoimmune and inflammatory diseases. Responsibilities: develop and execute global regulatory strategies, manage key health authority interactions (FDA EoP2, EMA Scientific Advice), oversee submissions (INDs, CTAs, amendments), assess regulatory risks, and lead cross-functional teams ensuring compliance and strategic alignment. Qualifications: minimum 10 years in biotech/pharma, with at least 8 years in drug/biologic regulatory affairs, proven leadership in global regulatory strategies, experience with complex programs and major agency interactions, extensive knowledge of biologics regulations including ICH, GCP, and region-specific rules. Preferred: experience with monoclonal antibodies, biologic-device combos, rare disease development, expedited pathways, and Phase 3 activities. Education: bachelor’s in a scientific discipline; advanced degrees or certifications preferred. HighValue: biologics, monoclonal antibodies, biologic-device combinations, autoimmune/inflammatory indications, early to late-stage development, global regulatory engagement, and strategic leadership. WorkSetup: Not specified.