At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
岗位描述：简明扼要的介绍该岗位的首要目的和主要责任。
Position Brand Description: Concisely summarize the primary purpose & key accountabilities of the position.
维护礼来苏州相关的工厂许可证、制造和生产的所有产品的质量法规证书和法规承诺文件。Maintain the permit &license relevant to manufacturing, market authorizations for Lilly Suzhou and maintain Regulatory Commitment Matrix (COMTRIX) for manufacturing part for exported products and local products定期递交工厂法规申请文件保证工厂运营的合法性。
Submit applications to regulatory authority periodically to maintain the legality of site operation.
确保相关技术文件，工艺流程和工厂行为符合法规要求。例如，对变更，偏差或规范/PFD提供法规方面的评估。
Ensure technical documents, site process and practices to be in compliance with regulatory requirements through review or involvement in site activities, e.g. regulatory assessment of any planned changes or deviations or spec/PFD, etc.追踪外部法规的变化对工厂的影响，使工厂活动符合法规要求。
Monitoring external regulatory changes and conducting regulatory interactions pertaining GMPs.
主要职能：按重要性，描述实现岗位目标必须完成的主要职责，应涵盖该岗位90%以上的工作内容。
Key Objectives/Deliverables: In order of importance, describe the primary responsibilities, which must be completed to achieve the objects of the position. The description should cover approximately 90% or more of the job content.
负责工厂许可证、法规注册文件和法规承诺文件的维护。To be responsible for Manufacturing Permit, Market Authorizations, Regulatory Commitment Matrix (COMTRIX) Maintenance.
负责苏州工厂国内生产许可证，GMP的申请和维护。To be responsible for Lilly Suzhou manufacture license and GMP license application and maintenance.
理解法规承诺文件内容，并确保相关文件被维护。
Understanding of content requirements, including COMTRIX and core dossiers and apply expertise to ensure appropriate level of commitments is maintained.负责法规承诺文件建立以及相关内容更新与批准的生产变更和流程要求相一致。Responsible for COMTRIX establishment based on approval dossiers and preparing updates to COMTRIX consistent with approved manufacturing changes and procedural requirements.支持产品的技术转移以及上市后变更的管理
Support product technical transfer and post approval change management
积极的参与涉及到苏州工厂产品的法规策略的讨论， 确保法规上的可执行性。Actively involved in the regulatory strategy planning for all the products related to Suzhou site, to ensure the feasibility from the regulatory perspective.
跟其他部门合作（CMC团队，法规，技术支持以及QC等）及时提供涉及欧盟和中国的资料Work with other functions (Global CMC, RA, TSMS and QC etc.) to provide the submission information to EU and China authorities in a timely manner.
跟踪递交的法规进程Follow up all the regulatory status of the submissions
评估上市后的变更，以及确定必要的法规方面的行动。如有必要，咨询法规部门Evaluate the post approval changes and define the necessary regulatory activities according to applicable guidance. And consultant with authorities, if necessary.
负责与政府部门沟通。To be responsible for communication and interaction with the regulatory body.
负责委托加工药品的备案和核销,生产关键设施备案，GMP证书公证，药品生产许 可证变更等法规要求备案事项。To be responsible for multiple types of filing according to FDA requirements.负责平时的政府部门沟通和咨询，确保与LQS112的符合性。
To be responsible for communication and consultant with regulatory body and ensure the compliance with LQS112.申请并协调法规部门的GMP审计。
Apply for and coordinate the regulatory agency GMP inspection.负责对工厂发生的相关偏差和变更提供法规影响的分析。
To be responsible for regulatory assessment for any change and deviation.
负责评估外部法规的变化对苏州工厂的影响，使工厂的行为符合法规要求。To be responsible for monitoring external regulatory change and assessing the impact on Lilly Suzhou to ensure all activities in Suzhou plant are compliance with current regulatory.
基本要求：写明与工作相关，履行此岗位基本职能所必需的资质要求，包括：教育/执业资格/证书，相关经验，技术和/或其他工作相关技能（操作技能，外语，计算机等）。
Basic Requirements: Indicate qualifications that are job related, necessary for the performance of an essential function of this position including education/licenses/certifications, relevant experience, technical and/or other job-related skills (Operational skill, foreign language, computer and etc.).
本科及以上学历Bachelor degree or above,
至少3年的医药行业RA，QA或者技术职位经验At least three years of experience in RA, QA or Technical Position in pharmaceutical industry.
较强的组织，协调以及项目管理能力Strong organizational skills, facilitation, and project management skills
流利英语说，写和读Capable of speaking, writing and read in English in fluency
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