Associate Director, Global Regulatory Project Management

Job Title: Associate Director, Global Regulatory Project Management Job Location: Remote (US) Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: 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. Job Description General Description: The Associate Director, Global Regulatory Project Management (AD, Global RPM) is a strategic leader responsible for translating and executing regulatory strategies across the global drug development lifecycle. This role blends deep regulatory expertise with advanced project management skills, driving successful NDA/BLA/MAA submissions and ensuring cross-functional integration across regions. The AD, Global RPM proactively anticipates regulatory challenges, influences business decisions, and champions process improvements to secure and maintain market access for products worldwide. Essential Functions of the Job: Strategic Global Leadership Translate, implement, and advise on 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.). Act as a key advisor to the GRL/RRL, providing strategic regulatory oversight and recommendations for global product development, submissions, and lifecycle management. Integrate functional expertise with business 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 wit