Reg Affairs Assoc I

Job description

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 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 programs, projects or processes specific to 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, external vendors and clients as needed to facilitate communication 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 operations, policies and procedures to ensure compliance with legal, regulatory and internal standards. KNOWLEDGE, EXPERIENCE, AND SKILLS Good verbal and written English language skills and interpersonal communication skills required. Bachelor’s 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 。 For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.