Manager, Global Regulatory Strategy

Lead US regulatory strategy to drive successful registration and lifecycle management for rare-disease, technologically complex products. Serve as US regulatory lead and point of contact with regulatory authorities, coordinating meetings and information packages. Provide strategic regulatory input across assigned programs, advise on pipeline and line extensions, and execute aspects of global/regional regulatory affairs to ensure integration of local objectives into global plans. Manage submissions, monitor evolving guidance, and uphold ethics, transparency, and high-quality regulatory practices.