Director, Global Regulatory Project and Submission Management at BeOne Medicines

Job description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: The Director, Global Regulatory Project Management (Director, Global RPM) is a senior strategic leader responsible for supporting, influencing, translating, and executing oncology regulatory strategies across the global drug development lifecycle. This role combines deep regulatory expertise with advanced project management and organizational leadership, driving successful NDA/BLA/MAA submissions and ensuring seamless cross-functional integration across regions. The Director, Global RPM proactively anticipates regulatory challenges, influences decisions, and champions process improvements to secure on-time submissions and maintain market access for products worldwide Essential Functions of the Job: Strategic Global Leadership Support, translate, and implement global regulatory strategies for development programs, ensuring alignment with business objectives and long-term vision across all major regions (US, EU, China, APAC, LATAM, etc.). Serve as a principal advisor to the Global Regulatory Lead (GRL) and Regulatory Regional Leads (RRL), providing strategic regulatory oversight and recommendations for global product development, submissions, and lifecycle management. Integrate functional regulatory expertise with PM knowledge to solve complex problems and make sound decisions for the organization on a global scale. Maintain awareness of global regulatory environments, policy trends, and competitive landscapes, assessing impact and adapting strategies accordingly. Global Project Management Excellence 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. Act as the “COO” to the Global Regulatory Lead, translating strategic regulatory vision into actionable project plans, driving operational execution, and ensuring all cross-functional activities are coordinated and delivered on time. Organize and facilitate cross-functional meetings with global teams to coordinate, plan, and track submission activities, driving accountability and alignment among stakeholders worldwide. 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, ensuring timelines and quality standards are met globally. Cross-Regional Collaboration Build partnerships with senior stakeholders and cross-functional teams (clinical, medical, safety, CMC, commercial) across regions to achieve strategic business goals through knowledge sharing and collaboration. Liaise and negotiate with cross-functional teams and regulatory authorities to expedite submission timelines and resolve key regulatory issues in all relevant markets. Mentor, guide, and develop junior and mid-level staff in project planning, regulatory processes, and professional development, fostering a global mindset. Continuous Improvement Champion process optimization and improvement initiatives within the global regulatory PM function. Lead the development and implementation of regulatory processes and policies, fostering a culture of excellence and innovation across regions. undefined Supervisory Responsibilities: Proficiency with project management and document management tools, such as Smartsheets, MS Project, and Power BI. Advanced skills in the Microsoft Office suite (Word, Excel, PowerPoint, Outlook). Ability to quickly learn and adapt to new software platforms and digital collaboration tools. Experience with electronic document management systems and regulatory submission pl