**For Current Gilead Employees and Contractors:** Please log onto your Internal Career Site to apply for this job. At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** **JOB DESCRIPTION** + Partner with China Regulatory Affairs team to implement CMC strategy for assigned products/projects entering in/or established in China (clinical and commercial). + Partner with central CMC Regulatory Affairs team to support development and life cycle management aspects of China regulatory CMC submissions. + Ensure CMC dossiers to meet ICH content requirements, as well as the specific local requirements, including those certificates. + Support the conduction of China-specific risk assessments on global CMC regulatory tasks and provide guidance to corporate management. + Execute and closely monitor the China CMC regulatory plans for assigned projects, including the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development. + Advise China regulatory strategies and solutions for complex CMC challenges for assigned Gilead product submissions and commercial registrations, including risk mitigation. + Ensure regulatory conformance and consistency for assigned products in China in compliance with regulatory requirements and internal procedures. + Demonstrate and model Gilead’s Core Values and Leadership Commitments; Embrace and comply with global CMC principles of integrity. **QUALIFICATIONS** + A scientific degree in life sciences or pharmaceutical sciences with directly relevant professional experiences in biologics and chemical drugs CMC development, registration, or CMC technical areas of at least 8 years with a BS, 6 years with an MS, or 2 years with an PhD, PharmD, or MD. + Demonstrated track record in defining innovative CMC regulatory strategies and implementing at a platform level. + Experiences with executing NDA/BLA submission and approval, e.g., therapeutic antibody or innovative small molecule, major CMC variations submission and approval, including direct CDE/NIFDC technical interactions. + Systematic knowledge of ICH requirements, and an understanding of current global trends in CMC Regulatory Affairs. + Application of sound and accurate judgment to make timely decisions or escalation. + Demonstrated success in driving project to support operational goals and contribute to the development and implementation of regulatory submission plan. + Excellent strategic acumen, collaboration, and communication skills are required. + Demonstrated commitment to inclusion, collaboration, and teamwork. + Preferred to have working experiences at health authorities. + Fluent in spoken and written English. + Located in Beijing or Shanghai. **Gilead Core Values** + Integrity (Doing What’s Right) + Inclusion (Encouraging Diversity) + Teamwork (Working Together) + Excellence (Being Your Best) + Accountability (Taking Personal Responsibility) 在吉利德，我们致力于为所有人创造一个更健康的世界。过往逾35年间，我们在HIV、病毒性肝炎、COVID-19、肿瘤等危及生命的疾病领域持续推动药物革新，改善患者生活，并在全球范围内提升药物可及。未来，我们将继续应对全球最具挑战的健康问题，为实现这一使命，需要我们同心协力、坚定信念和不懈努力。 每个你，都将在我们探索和推动改变生命的科学创新进程中扮演至关重要的角色，“吉客”是我们得以实现伟大愿景的重要伙伴，我们期待充满热忱、志存高远的你，在这里创造真正的影响力。 我们深信卓越的管理者才能赋能卓越的团队，每一位吉利德领袖都致力于为“吉客”创造积极的工作体验。无论你现在、抑或有志向成为团队管理者，都是塑造“吉客文化”的关键“引擎”，让我们共同创造一个让每位“吉客”都能感受到包容、持续成长和充分赋能的职场环境，实现未来无限可能。 加入吉利德科学，携手，突破不可能！ **注册事务CMC高级经理- 中国** **主要职责** 中国CMC 法规事务高级经理 - 负责实施吉利德在中国的全球产品组合策略，并维护吉利德在中国销售产品的 CMC 法规事务。CMC RA 是吉利德药物开发与制造组织(PDM)的一部分。 该职位将为指定项目实施 CMC 策略，确保 CMC 监管提交（临床和商业）的“首次正确”全球批准，并通过维护全球许可来合理运营。 此外，该职位还将负责支持 CMC 监管指南、ICH、法规和监管实操的解释和实施，以确保在中国的批准。 该职位将直接向中国CMC RA负责人汇报。 **职位描述** • 与中国法规事务团队合作，实施准备开发/或已在中国上市的指定产品/项目（临床和商业）的CMC 策略。 • 与总部CMC 法规事务团队合作，支持中国CMC 资料提交的开发和生命周期管理工作。 • 确保CMC 档案及相应证明信材料满足ICH 内容要求以及特定的当地要求。 • 在针对全球CMC 法规活动开展针对中国的风险评估方面发挥支持作用，并为管理层提供指导。 • 执行并密切跟踪指定项目的中国CMC注册计划，包括与PDM、法规事务和临床开发等其他职能部门密切合作，监督递交和审批流程。 • 针对指定的吉利德产品递交和商业注册的复杂CMC 挑战提供建议，包括排除风险在内的中国注册策略和解决方案。 • 确保指定产品在中国的监管合规性和一致性，符合监管要求和内部程序。 • 展示和示范吉利德的核心价值观和领导力承诺； 拥护并遵守全球 CMC 诚信原则。 **任职资格** • 拥有生命科学或制药科学学位，在生物制品和化学药物 CMC 开发、注册或 CMC 技术领域拥有至少8 年（学士学位）、 6 年（硕士）或 2 年（博士、药学博士或医学博士）直接相关的专业经验。 • 在开发创新CMC 注册策略和在平台层面上实施方面具有良好的记录。 • 拥有最新的 NDA/BLA 提交和批准经验，例如治疗性抗体或创新小分子药物、重大 CMC 变更提交和批准，包括直接 与CDE/NIFDC的技术互动。 • 系统了解ICH 要求，并了解CMC 注册事务的当前全球趋势。 • 运用合理而准确的判断来及时做出决策或上报。 • 在领导项目团队支持运营目标并为注册递交计划的制定和实施做出贡献方面取得了成功。 • 需要出色的战略敏锐度、协作和沟通技巧。 • 表现出对包容、协作和团队合作的承诺。 • 有监管部门工作经验者优先。 • 英语口语和书写流利。 • 工作地点可在北京或上海。 **For Current Gilead Employees and Contractors:** Please log onto your Internal Career Site to apply for this job. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.