Director, Senior Global Regulatory Lead

Lead science-driven global regulatory strategies for assigned products across development, registration, and post-marketing. Partner with cross-functional product teams, guide regulatory interactions with health authorities, oversee strategic regulatory deliverables, and advise leadership on product development decisions. Develop and lead integrated global regulatory strategies across product development, registration, and post-marketing. Represent Global Regulatory Affairs on Product Strategy Teams and guide cross-functional regulatory decision-making. Lead strategic interactions with the FDA, EMA, and regional health authority partners. Coordinate Global Regulatory Affairs Strategy Team priorities, responsibilities, and deliverables. Review and advise on protocols, Target Product Profiles, and other product development documents. Oversee strategic regulatory documents, including briefing books, orphan drug designations, and pediatric study plans. Global regulatory strategy development Regulatory affairs for drug development FDA regulatory requirements EMA regulatory requirements Health authority engagement Product lifecycle management Regulatory submission strategy Clinical protocol review Target Product Profile review Regulatory intelligence