BeOne Medicines USA, Inc. is a rapidly growing company focused on fighting cancer. The Associate Director, Global Regulatory Project Management is responsible for leading regulatory strategies and managing submissions across global markets, while ensuring compliance and collaboration among cross-functional teams.

Responsibilities:

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
Provide direct or indirect supervision to Regulatory Project Management staff, including mentoring, coaching, and supporting professional development
Guide and develop junior team members to support their growth and long-term success within the organization
Oversee cross-functional project teams and coordinating activities across global stakeholders
Serve as a leader and role model within the Regulatory Project Management function, fostering a collaborative and high-performance culture

Requirements:

Bachelor's degree in Science or related discipline
Minimum 8+ 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
Proficiency with project management and document management tools (e.g., Smartsheets, MS Project, Power BI, MS Office suite)
Proactive, not reactive; 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 preferred
Experience with electronic document management systems and regulatory submission platforms is preferred
PMP or similar certification preferred

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