(Sr.) Director, Regulatory Affairs Lead (Global Regulatory Lead)

of the Job: Accountable for providing high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in multiple countries, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions. Use extensive knowledge of US, China, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to allocated assets. Oversee the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met. Review sections of IND/CTA, NDA/MAA/NDS, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements. Liaise and negotiate with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes. Maintain awareness of global regulatory environment and assess impact of changes on business and product development programs. Facilitate policy and development of standard interpretation of global regulation. Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business. Manages critical issues, taking leadership for the regulatory contribution. Responsible for assisting with the development and implementation of regulatory processes. Consult with Advisory Committee for relevant topics and incorporate the ideas into strategy and execution if appropriate. Provide guidance to Execution Unit at regional and global level and ensure timely, quality, and efficient study planning and execution of associated clinical studies. Conduct regular review meetings with Execution Unit to mentor, support, and ensure all studies are tracking to quality and timeline. Report on study status, goals, operational KPIs, and enforce quality KPIs. Champions a global mindset and approach across GRA to foster collaboration and consistency across the organization. Participate company-wise standard discussion, finalization, and implementation. Other duties as assigned. Education Required: Bachelor’s degree required; advanced degree preferred. A minimum of 12 years in the biotechnology or pharmaceutical industry and a minimum of 5 years in a regulatory leadership capacity with a broad background in oncology. Computer Skills: Skilled in Microsoft Office Suite Other Qualifications: Experience of working as a lead in Regulatory Affairs across two or more major geographic areas, and experience of leading multiple FDA interactions for oncology products leading to Agency approval actions. Experience should clearly be demonstrative of managerial, leadership, and collaboration ability across multiple functional areas. Thorough understanding of drug development process, the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends. Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, developing, and implementing regulatory strategies with a proven track record of significant regulatory accomplishments. Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges and the ability to balance short-term needs with long-term vision. Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism. Excellent interpersonal skills and the ability to build and maintain positive work relationships to effectively interface at all levels across the organization. Fluent in written and verbal English. Desirable: knowledge of Mandarin. Travel: Up to 20%. Ability to travel domestically and internationally. 百济神州全球胜任力 当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。 ●团队协作 ●提供并征求坦诚及可行的反馈 ●自我认知 ●兼容并蓄 ●积极主动 ●开拓精神 ●持续学习 ●拥抱变化 ●结果导向 ●分析性思维/数据分析 ●卓越财务 ●清晰沟通 BeOne Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. ●Fosters Teamwork ●Provides and Solicits Honest and Actionable Feedback ●Self-Awareness ●Acts Inclusively ●Demonstrates Initiative ●Entrepreneurial Mindset ●Continuous Learning ●Embraces Change ●Results-Oriented ●Analytical Thinking/Data Analysis ●Financial Excellence ●Communicates with Clarity 求职者隐私申明： 百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息 ）。 由于百济神州在全球范围内开展业务，我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家（例如：美国）的服务器和数据库中，详情参见百济神州《求职者隐私政策》（百济神州官网 - 隐私政策 - 求职者隐私政策）。 如您主动向我们提供您的简历信息或其他个人信息，则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的，请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. Due to the reasonable business need for human resource management as a result of BeOne’s global operation, your personal information may be transferred and/ or stored in a server/database located in a third country (e.g., the United States) other than your own country. For further details, please refer to BeOne Job Applicant Privacy Policy (BeOne official website - Privacy Policy - Job Applicant Privacy Policy). If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeOne Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.

and standards are met. This role helps deliver the partnership studies that run on our Clinical SuperHighway, supporting seamless onboarding and high-quality execution of external partner projects in close partnership with the execution functions.