Director, Global Regulatory Project and Submission Management

BeOne Medicines is hiring a Director to lead global regulatory project management across oncology drug development. The role translates regulatory strategies into coordinated execution, leads global submissions, and supports cross-functional collaboration and process improvement.

Responsibilities:

• 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
• 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 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
• 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

Requirements:

• 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
• Bachelor's degree in Science or related discipline
• Minimum 10+ years of experience in regulatory project management and regulatory submissions, including both small molecules and biologics, with significant global exposure
• Demonstrated experience in strategic regulatory leadership, with a proven track record of successful submissions and regulatory PM accomplishments in multiple regions
• Experience leading cross-functional and cross-regional teams, influencing senior stakeholders globally
• Strong business acumen, strategic thinking, and ability to integrate multiple sources of data for sound decision-making
• Excellent verbal and written communication skills; able to understand and translate complex regulatory issues clearly to internal and external stakeholders worldwide
• Skilled in conflict resolution, negotiation, and fostering open communication across cultures
• Proactive, not reactive; knows the regulatory lifecycle and anticipates challenges and takes initiative to address them
• Demonstrates integrity, accountability, and strategic leadership
• Thrives in a global team environment and seeks excellence as the measure of success
• Able to balance multiple tasks, prioritize effectively, and meet deadlines across time zones and regions
• advanced degree
• Experience with electronic document management systems and regulatory submission platforms
• PMP or similar certification