Global Regulatory Lead, Regulatory Strategy - Global Regulatory Affairs - Infectious Disease/Vaccine

Role: Global Regulatory Lead (GRL) responsible for developing and executing global regulatory strategies across the product lifecycle. Objectives include ensuring seamless global regulatory compliance, facilitating successful submissions, and managing relationships with the US FDA. Responsibilities: lead cross-functional teams, shape development plans, oversee US FDA submissions (INDs, NDAs, BLAs), and foster external stakeholder relationships. Requirements: advanced scientific degree (PharmD, PhD) with 8+ years (or Bachelor’s/Masters with 10+ years) in regulatory affairs/drug development; deep knowledge of global regulatory procedures; experience with US, EU, China, Japan regulatory processes; strong leadership and communication skills. Preferred: experience in clinical and CMC regulatory sciences, therapeutic area expertise, risk management, and negotiation with regulatory agencies. High-Value: involvement with regulated pharmaceutical products, global regulatory strategy, US FDA interactions, cross-functional leadership, and international regulatory markets. Work setup: travel expected 10-15%.