Associate Director, Global Regulatory Project and Submission Management

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.

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.

• 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.

• 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.

• 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 to expedite submission timelines and support resolve key regulatory issues in all relevant markets.
• Mentor and guide junior staff in project planning, regulatory processes, and professional development, fostering a global mindset.

• Champion process optimization and improvement initiatives within the global regulatory PM function.
• Contribute to the development and implementation of regulatory processes and policies, fostering a culture of excellence and innovation across regions.

• This role has the potential to evolve into a formal people-manager position. Over time, responsibilities may include:
• Providing direct or indirect supervision to Regulatory Project Management staff, including mentoring, coaching, and supporting professional development.
• Guiding and developing junior team members to support their…