Director, Global Regulatory Project Management

📋 Description

• • As a Director, Global Regulatory Project Management at BeiGene, Ltd., you will be a pivotal senior strategic leader, instrumental in shaping and executing global oncology regulatory strategies throughout the entire drug development lifecycle. This role demands a unique blend of profound regulatory expertise, sophisticated project management acumen, and exceptional organizational leadership to ensure the successful navigation of critical regulatory milestones, including NDA/BLA/MAA submissions, and to foster seamless cross-functional integration across diverse global regions.
• • You will proactively identify and address potential regulatory challenges, influence key decisions, and champion continuous process improvements, all with the ultimate goal of securing timely submissions and maintaining vital market access for BeiGene's innovative products worldwide.
• • Your strategic global leadership will involve supporting, translating, and implementing global regulatory strategies for development programs, ensuring unwavering alignment with overarching business objectives and the company's long-term vision across major markets such as the US, EU, China, APAC, and LATAM.
• • You will act as a principal advisor to the Global Regulatory Lead (GRL) and Regulatory Regional Leads (RRLs), providing strategic regulatory oversight and expert recommendations for global product development, submission planning, and lifecycle management.
• • A key aspect of this role is the integration of deep functional regulatory expertise with robust project management principles to effectively solve complex problems and drive sound, globally-minded decisions for the organization.
• • You will maintain a keen awareness of evolving global regulatory environments, emerging policy trends, and the competitive landscape, critically assessing their impact and adapting strategies proactively.
• • In terms of global project management excellence, you will lead and meticulously manage complex regulatory submissions, including INDs/CTAs and NDAs/BLAs/MAAs, across multiple regions, ensuring strict adherence to ICH, US, EU, China, and other international regulatory requirements.
• • You will function as the operational backbone, the "COO," to the Global Regulatory Lead, translating strategic regulatory visions into actionable, detailed project plans, driving operational execution, and ensuring all cross-functional activities are harmoniously coordinated and delivered precisely on time.
• • Organizing and facilitating critical cross-functional meetings with global teams will be essential for coordinating, planning, and meticulously tracking submission activities, fostering accountability and ensuring alignment among diverse stakeholders worldwide.
• • Proactive identification of potential risks, the development of effective mitigation strategies, and the adept management of critical issues related to global regulatory submissions and strategy are paramount.
• • You will oversee the comprehensive preparation and submission of all necessary documentation to support investigational and marketing registration packages, guaranteeing that global timelines and quality standards are consistently met.
• • Fostering strong cross-regional collaboration is crucial. You will build robust partnerships with senior stakeholders and cross-functional teams, including clinical, medical, safety, CMC, and commercial departments across various regions, to achieve strategic business goals through shared knowledge and collaborative efforts.
• • You will serve as a key liaison and negotiator with cross-functional teams and regulatory authorities to expedite submission timelines and resolve critical regulatory issues in all relevant markets.
• • Mentoring, guiding, and developing junior and mid-level staff in project planning, regulatory processes, and professional growth will be an integral part of your role, cultivating a strong global mindset within the team.
• • You will champion process optimization and improvement initiatives within the global regulatory project management function, driving efficiency and effectiveness.
• • Leading the development and implementation of best-practice regulatory processes and policies will be essential, fostering a culture of excellence and innovation across all regions.
• • While not a primary focus initially, this role has the potential to evolve into a formal people-management position, which may include direct or indirect supervision, mentoring, coaching, and supporting the professional development of Regulatory Project Management staff, overseeing cross-functional project teams, and serving as a role model within the function.