• Translate, implement, and advise on global regulatory strategies for development programs • Act as a key advisor to the GRL/RRL, providing strategic regulatory oversight and recommendations for global product development, submissions, and lifecycle management • Lead and manage complex regulatory submissions (IND/CTA, NDA/BLA/MAA) across multiple regions, ensuring compliance with ICH, US, EU, China, and other international requirements • Organize and facilitate cross-functional meetings with global teams to coordinate, plan, and track submission activities • Proactively identify risks, propose solutions, and manage critical issues related to global regulatory submissions and strategy • Oversee preparation and submission of documentation to support investigational and marketing registration packages • Build partnerships with senior stakeholders and cross-functional teams (clinical, medical, safety, CMC, commercial) across regions • Mentor and guide junior staff in project planning, regulatory processes, and professional development • Champion process optimization and improvement initiatives within the global regulatory PM function