[Remote] Director, Global Regulatory Project Management

Note: The job is a remote job and is open to candidates in USA. BeOne Medicines is a rapidly growing company focused on fighting cancer, seeking a Director of Global Regulatory Project Management. This role involves leading global regulatory strategies and project management for oncology drug development, ensuring compliance and successful submissions across multiple regions.ResponsibilitiesSupport, 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 managementIntegrate functional regulatory expertise with PM knowledge to solve complex problems and make sound decisions for the organization on a global scaleMaintain awareness of global regulatory environments, policy trends, and competitive landscapes, assessing impact and adapting strategies accordinglyLead and manage complex regulatory submissions (IND/CTA, NDA/BLA/MAA) across multiple regions, ensuring compliance with ICH, US, EU, China, and other international requirementsAct 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 timeOrganize and facilitate cross-functional meetings with global teams to coordinate, plan, and track submission activities, driving accountability and alignment among stakeholders worldwideProactively identify risks, propose solutions, and manage critical issues related to global regulatory submissions and strategyOversee preparation and submission of documentation to support investigational and marketing registration packages, ensuring timelines and quality standards are met globallyBuild partnerships with senior stakeholders and cross-functional teams (clinical, medical, safety, CMC, commercial) across regions to achieve strategic business goals through knowledge sharing and collaborationLiaise and negotiate with cross-functional teams and regulatory authorities to expedite submission timelines and resolve key regulatory issues in all relevant marketsMentor, guide, and develop junior and mid-level staff in project planning, regulatory processes, and professional development, fostering a global mindsetChampion process optimization and improvement initiatives within the global regulatory PM functionLead the development and implementation of regulatory processes and policies, fostering a culture of excellence and innovation across regionsProviding direct or indirect supervision to Regulatory Project Management staff, including mentoring, coaching, and supporting professional developmentGuiding and developing junior team members to support their growth and long-term success within the organizationOverseeing cross-functional project teams and coordinating activities across global stakeholdersServing as a leader and role model within the Regulatory Project Management function, fostering a collaborative and high-performance cultureSkillsBachelor's degree in Science or related discipline; advanced degree preferredMinimum 10+ years of experience in regulatory project management and regulatory submissions, including both small molecules and biologics, with significant global exposureDemonstrated experience in strategic regulatory leadership, with a proven track record of successful submissions and regulatory PM accomplishments in multiple regionsExperience leading cross-functional and cross-regional teams, influencing senior stakeholders globallyStrong business acumen, strategic thinking, and ability to integrate multiple sources of data for sound decision-makingExcellent verbal and written communication skills; able to understand and translate complex regulatory issues clearly to internal and external stakeholders worldwideSkilled in conflict resolution, negotiation, and fostering open communication across culturesProficiency with project management and document management tools, such as Smartsheets, MS Project, and Power BIAdvanced skills in the Microsoft Office suite (Word, Excel, PowerPoint, Outlook)Ability to quickly learn and adapt to new software platforms and digital collaboration toolsExperience with electronic document management systems and regulatory submission platforms is preferredAdvanced degree preferredPMP or similar certification preferredBenefitsNon-Commercial roles are eligible to participate in the annual bonus planCommercial roles are eligible to participate in an incentive compensation planAll Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awardsAll employees are eligible to voluntarily participate in the Employee Stock Purchase PlanThe Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and WellnessCompany OverviewBeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. It was founded in 2010, and is headquartered in Klein-basel, Basel-Stadt, CHE, with a workforce of 10001+ employees. Its website is https://beonemedicines.com.Company H1B SponsorshipBeOne Medicines has a track record of offering H1B sponsorships, with 3 in 2026, 20 in 2025. Please note that this does not guarantee sponsorship for this specific role.