Reg Affairs Assoc I

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

RESPONSIBILITIES

• Ensure timely and accurate payment to NMPA/CDE/NIFDC for product registration applications. Proactively track payment status and resolve any issue internally and externally to prevent any delays.
• Support budget management activities for the functional area including but limited to tracking expenditure monitoring invoices and purchase orders coordinating vendor payments supporting translation or operational budgets and maintaining budget records in accordance with company policies and procedures.
• Coordinate and oversees programsprojectsor processesspecificto the functional area ensuring alignment with organizational goals and deadlines.
• Maintain functional records regulatory systems and tracking tools including data entry milestone updates document tracking and reporting in relevant business systems.
• Support the head of Regulatory Affairs on logistic arrangement for business trip and daily admin activities. And help the RA head engage the team and build good working environment.
• Serve as an administrative liaison between internal teams externalvendorsand clients as needed tofacilitatecommunication and resolve discrepancies. Event/meeting/global visit/annual meeting/x-functional workshop.
• Oversee the management of U-Key access for CDE submission enduring strict compliance with security.
• May act as a point of contact for clients and vendors managing proposals and supporting customer service.
• Prepare coordinate and maintain communication materials trackers meeting outputs and project documentation (for local regulatory and X-functional teams)
• Maintain a detailed knowledge of company and functional operationspoliciesand procedures to ensure compliance with legalregulatoryand internal standards.

KNOWLEDGE EXPERIENCE AND SKILLS

• Good verbal and written English language skills and interpersonal communication skills required.
• Bachelors degree or above in healthcare management pharmacy Life Sciences or a related discipline preferred.
• 3 years experience in drug development functions preferred.
• Be flexible and proactive with strong team spirit.
• Demonstrated ability to manage multiple activities simultaneously and deliver high-quality results within timelines.
• Ability to collaborate cross-functions in administrative activities and a good helper for the RA head and the RA team.

岗位职责

负责药品注册申请相关费用向国家药品监督管理局NMPA药品审评中心CDE及中国药品检定研究院NIFDC的及时准确支付工作主动跟踪付款进展并协调内部及外部相关方解决问题确保注册项目不因付款问题而延误

支持部门预算管理工作包括但不限于费用跟踪发票及采购订单管理供应商付款协调翻译及运营预算支持并按照公司相关政策和流程维护预算记录

协调并推动部门相关项目计划及流程管理工作确保与部门目标及时间节点保持一致

负责部门档案注册管理系统及跟踪工具的维护工作包括数据录入关键里程碑更新文件跟踪及相关业务系统中的报告管理

支持注册事务负责人完成差旅安排及日常行政事务协助提升团队凝聚力营造良好的团队合作氛围和工作环境

作为内部团队外部供应商及合作方之间的联络窗口协助沟通协调并解决相关问题支持会议活动全球访问年度会议及跨职能研讨会等事务的组织协调与执行

负责CDE递交相关U-Key权限的管理工作确保符合公司信息安全和合规要求

作为供应商及外部合作方的联络人之一协助管理相关提案并提供必要的运营支持

负责准备协调和维护沟通材料项目跟踪表会议纪要及项目文档为注册团队及跨职能团队提供支持

持续了解公司及部门运营模式政策和工作流程确保各项工作符合适用法律法规以及公司内部合规要求

知识经验与技能要求

具备良好的英语口头及书面表达能力以及良好的人际沟通能力

医疗健康管理药学生命科学或相关专业本科及以上学历优先

具有3年以上在药物研发部门相关工作经验者优先

具备良好的适应能力和主动性具有较强团队合作精神

具备同时管理多项工作任务的能力能够在约定时间内高质量完成工作

具备良好的跨职能协作能力能够在行政及运营支持工作中有效支持注册事务负责人及注册事务团队

具备良好的跨职能协作能力能够在行政及运营支持工作中有效支持注册事务负责人及注册事务团队

Please apply via the Internal Career Opportunities portal in Workday.