Reg Affairs Assoc I

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About the role

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。 ·    

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