Associate Director, Global Regulatory Project Management

📋 Description

• • As an Associate Director, Global Regulatory Project Management (AD, Global RPM) at BeiGene, Ltd., you will be a pivotal strategic leader responsible for translating and executing complex global regulatory strategies throughout the entire drug development lifecycle. This role demands a unique blend of deep regulatory expertise and advanced project management acumen, essential for driving successful New Drug Applications (NDA), Biologics License Applications (BLA), and Marketing Authorization Applications (MAA) submissions. You will be instrumental in ensuring seamless cross-functional integration across all major global regions, proactively identifying and mitigating regulatory challenges, influencing critical business decisions, and championing continuous process improvements to secure and maintain market access for BeiGene's innovative products worldwide.
• • In this strategic global leadership capacity, you will translate, implement, and provide expert advice on global regulatory strategies for development programs. This involves ensuring strict alignment with overarching business objectives and the long-term vision of the company across diverse markets including the US, EU, China, APAC, and LATAM. You will serve as a key advisor to the Global Regulatory Lead (GRL) or Regional Regulatory Lead (RRL), offering strategic regulatory oversight and making critical recommendations for global product development, submission pathways, and lifecycle management. Your ability to integrate functional expertise with comprehensive business knowledge will be crucial for solving complex problems and making sound, globally-minded decisions.
• • You will maintain a keen awareness of evolving global regulatory environments, emerging policy trends, and the competitive landscape, assessing their potential impact and adapting strategies proactively. This foresight is essential for navigating the dynamic pharmaceutical industry and ensuring BeiGene remains at the forefront of regulatory compliance and innovation.
• • Driving global project management excellence is at the core of this role. You will lead and manage intricate regulatory submissions, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTA), NDAs, BLAs, and MAAs, across multiple regions. Ensuring compliance with ICH guidelines, as well as specific US, EU, China, and other international regulatory requirements, will be paramount. You will act as the operational backbone to the Global Regulatory Lead, translating strategic regulatory vision into actionable project plans, driving efficient operational execution, and ensuring all cross-functional activities are meticulously coordinated and delivered on time.
• • Organizing and facilitating cross-functional meetings with global teams will be a regular responsibility, focusing on coordinating, planning, and tracking submission activities. This will involve driving accountability and fostering alignment among diverse stakeholders worldwide. You will proactively identify potential risks associated with global regulatory submissions and strategy, propose effective solutions, and manage critical issues to resolution. Furthermore, you will oversee the preparation and submission of all necessary documentation to support investigational and marketing registration packages, rigorously ensuring that global timelines and quality standards are consistently met.
• • Building robust partnerships with senior stakeholders and cross-functional teams—including clinical, medical, safety, CMC, and commercial departments—across all regions is vital. These collaborations will be key to achieving strategic business goals through effective knowledge sharing and teamwork. You will also liaise and negotiate with these cross-functional teams to expedite submission timelines and support the resolution of key regulatory issues in all relevant markets. A significant aspect of this role involves mentoring and guiding junior staff in project planning, regulatory processes, and professional development, cultivating a strong global mindset within the team.
• • You will champion process optimization and improvement initiatives within the global regulatory project management function, contributing to the development and implementation of best-in-class regulatory processes and policies. This commitment to continuous improvement will foster a culture of excellence and innovation across all regions.
• • While this role may evolve into a formal people-management position, it currently focuses on project leadership. Future responsibilities could include direct or indirect supervision of Regulatory Project Management staff, involving mentoring, coaching, and supporting their professional growth. You will guide and develop junior team members, oversee cross-functional project teams, and serve as a role model within the Regulatory Project Management function, promoting a collaborative and high-performance culture.