Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden

Job Information职位信息

Job title职位名称: RSO Specialist 工厂法规专员

•    Location工作地点： Sanofi Beijing site 赛诺菲北京工厂
•    % Remote working and % of travel expected 远程办公和出差的概率：10%
•    Job type工作类型: Permanent长期, Full time全职
•    Site/Unit 区域/事业部：M&S China中国制造与供应事业部

About the job工作职责

Our Team我们的团队：
Manufacturing & Supply consists of 3 manufacturing platforms based on global business units, as well as supporting functions of Quality, Market Supply and Strategy. We are committed to making best class medicines with excellent strategies and tools and delivering them to our patients.
制造与供应事业部包含以3个全球事业部为基础的制造平台，以及质量、供应商、精益战略等支持部门。致力于用优异的战略和工具制造优质的药品并传递到患者手中。

Main responsibilities职责描述：
Please indicate here the main job responsibilities请列举该职位的主要工作职责。
•    Evaluate the change in regard of the regulatory aspect, and get regulatory assessment/ strategy from RA, Reg CMC. 评估变更对合规性的影响，与注册部门RA、Reg CMC部门沟通得到评估结果和注册计划。
•    Support the registration department for registration activities related to the site. Responsible for the license validity of GMP and product registration. 支持与工厂相关的注册工作。负责维护工厂GMP 及产品注册相关的证照的有效性。
•    Compile and prepare technical document to be provided to RA. Ensure the change be implemented after approval by health authority and to ensure that site documentation is updated in regards of approved changes. 汇总需要工厂提供给注册的技术文件。确保需要经过药品监督管理部门批准的变更在得到批准后方可实施，并确保所有与变更相关的文件得到修订。
•    Follow registration submission/approval status concerning the products of the site and communication within the site in order to ensure adequate implementation.追踪与工厂产品相关的注册提交及批准状况，及时在工厂内部沟通，确保适当实施。
•    File in BJ-MPA concerning GMP related change, e.g. manufacturing license changes, key production utility / equipment change. 完成药品监督管理局和GMP相关的备案工作，如生产许可证的改变、关键生产设施/设备的改变等。
•    Prepare the submission document for GMP compliance inspection. Be the contact person for the HA inspection and participate to regulatory inspections, audits. 准备GMP符合性检查资料。作为药监部门审计的联络人和参与官方检查。
•    Notify site relative to regulatory intelligence (awareness function). Follow up the gap analysis of regulation and related CAPA. 通报药品新法规和新动向给工厂内相关部门，跟踪和推进法规的差距分析和纠正预防措施。
•    Support to identify the applicable Global Quality Directives, Operational Quality Standards and regulations, support with relative department to perform gap analysis.支持工厂内对全球质量政策,标准和法规要求的差距识别，支持各部门进行差距分析。
•    Interpret regulatory requirements, provide regulatory knowledge and proper assessment for the business needs. 提供对法规的解读，为业务的需求提供法规知识及评估。
•    Monitor the regulations intelligence and lead related functions to identify the gap, establish the CAPA and follow up the completion.关注法规情报并且引导相关部门识别风险，制定纠正预防措施以及跟踪其实施。
•    Perform certificate maintenance activities related with medical device according to the current Measures for the Supervision and Administration of Medical Devices. 依据现行医疗器械经营监督管理办法，执行医疗器械证照资质维护相关活动。
•    Writes CMC regulatory documents/dossiers to be dispatched to regulatory affairs functions for submission. 撰写药学注册文件，传递给注册部门用于递交。
•    Coordinates CMC writing performed by another entity (internal or external).协调工厂内外部门药学文件的撰写。
•    Optimizes the content of CMC dossiers to facilitate the management of future changes.优化药学文件内容，保证持续合规性，以促进上市后变更的管理。
•    Prepares with contribution of site experts Answers to questions from Health Authorities. 在工厂SME支持下准备药监部门的问题回复。
•    Supports Marketing Authorisations worldwide (territory extensions, renewals, site registrations and transfers…) by writing the corresponding CMC documents/dossiers and collecting GMP related documents from his/her site(s). 通过撰写相应的CMC文件/档案并从其负责的生产厂收集GMP相关文件，支持全球范围内的上市许可（地域扩展、再注册、场地注册和转移等）
•    Consolidates regulatory activities in a planning tool.用规划工具整合法规活动。
•    HSE Responsibilities of the Quality Department: 质量部HSE职责：
➤Responsible for implementing the company's HSE regulations, ensuring that the company's HSE system measures are applied to every specific aspect.负责贯彻公司HSE的有关规定，把公司HSE制度的措施贯彻到每个具体环节。
➤Incorporate HSE work into the work plan. 将HSE工作纳入工作计划中。
➤Organize and implement the department's HSE management objective plans, and put into practice HSE rules and regulations, HSE operating procedures, and HSE technical measure plans.组织实施本部门HSE管理目标计划，落实HSE规章制度、HSE操作规程和HSE技术措施计划。
➤Regularly conduct HSE hazard identification and rectification work within the department, develop improvement plans, and complete hazard rectification on time. 定期开展本部门HSE隐患排查治理工作，制定整改计划并按时完成隐患整改。
➤Responsible for department-level HSE education and assessment work; promptly address opinions raised by employees. 负责部门级HSE教育与考核工作；及时处理员工提出的意见。
➤Actively cooperate with HSE management work to prevent various types of accidents. 积极配合HSE管理工作，防止各类事故的发生。
➤Regularly conduct department-level +QDCI meetings at all levels, combine with HSE8 requirements, timely and correctly fill out and provide feedback on various HSE issues, and actively implement improvements. 定期开展本部门各级+QDCI会议，结合HSE8要求，及时、正确填写和反馈各类HSE问题，并积极落实整改。
➤Participate in accident investigation and analysis work, analyse accident causes from a quality management perspective, and propose accident prevention measures. 参加事故调查分析工作，从质量管理角度分析事故原因，提出事故防范措施。
➤Responsible for developing the annual department PASS plan and organizing its implementation according to the schedule. 负责制定年度部门PASS计划，并按进度组织实施。
•    Sanofi (Beijing) Pharmaceutical Co., Ltd. Energy Policy: "Quality as the top priority, through technical, behavioral, human consciousness, continuously reduce the rate of energy consumption in product value, benefit the users, and promote company development". Good awareness of energy conservation is required, participate in energy saving actions, and assist in the continuous development of the energy management system.赛诺菲（北京）制药有限公司能源方针：“以药品质量为第一要务，通过技术手段，行为规范，人为意识，不断降低产品价值中的能耗比重，造福广大用户，促进企业发展”要求每位员工具有良好的节能意识，积极的节能行动，协助能源管理体系的持续开展
➤ Actively propose energy-saving projects积极提出节能方案
➤ Coordinate and support the development of energy-saving projects and give positive feedback  协调并支持节能项目的制定，积极反馈意见
➤ Coordinate and participate in the implementation of energy-saving projects协调并参与节能项目的执行
➤ Participate in internal audit of energy management system参与能源管理体系的内部评审
•    Execute any other works not mentioned before coming from team manager. 执行部门经理安排的其他未提及的工作。
About you 任职资格:
List here ideally the must-haves criteria to be successful on the role. 
请列出胜任该职位所必须具备的条件。

•    Experience: At least 3 year-experience in quality management or regulatory at international companies are needed. Familiar with registration processes in key markets such as the EU, US, and Southeast Asia are preferred. 
工作经验: 至少3年跨国公司质量保证或注册方面的工作经验。熟悉欧盟、美国、东南亚等主流市场注册流程者优先。 
•    Soft skill: Must be problem solving oriented. Have a good knowledge of expertise for different functions and good team work skills to coordinate and influence others.
通用技能: 须具备善于解决问题的能力和主动性。具备多种业务知识和团队合作的能力影响他人。
•    Technical skill: An experience in Production and/or QC. Knowledge of Chinese Pharmaceutical rules is mandatory as well as basic knowledge of international GMP’s. Have experiences in registration or related work experiences.
专业技能: 具备生产和/或质量控制方面的工作经验。须具有中国药品管理知识及国际GMP的基本知识。具备注册或注册有关的工作经验。
•    Education: Major in Pharmaceutical Sciences or similar disciplines.
教育背景: 药学或相关专业。
•    Languages: Good English writing and spoken. Fluent in English (CET-6 or equivalent), capable of drafting technical documents (e.g., CE/FDA submissions) and communicating in cross-border meetings.
语言要求: 英语说、写良好。英语流利（CET-6或同等水平），能独立撰写英文技术文件（如CE/FDA申报材料）、参与跨国会议及邮件沟通
•    Play to Win Behaviors: Stretch; Take Action; Act for Patients & Customers; Think One Sanofi
全力致胜行为: 超越自我, 主动出击, 以患者和客户为本, 团结一致
Pursue progress, discover extraordinary进无止境，探索菲凡
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. 
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. 
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! 
进步，外部可见。更好的药物，更好的效果，更高的科学。但是进步离不开人去创造——来自不同背景、不同地区、担任不同岗位的人。所有人都团结在“创造奇迹的渴望”这一使命下。让我们成为这样的人。
在赛诺菲，不分种族、肤色、血统、宗教、性别、国籍、性取向、年龄、公民身份、婚姻状况、残疾或性别认同，我们为所有人提供平等的机会。
观看我们的 ALL IN 视频，并在 sanofi.com 网站上查看我们有关多元化、公平性、包容性的举措。