Job title职位名称: Regulatory Site Officer/工厂注册主管

• Location工作地点： Hangzhou Site 杭州工厂

About the job工作职责

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Regulatory Site Officer within our M&S China-HGZ Site, will be to making best class medicines with excellent strategies and tools and delivering them to our patients.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

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。

General Mission职责概述

• Implement and monitor site regulatory compliance tasks to ensure that site regulatory compliance is continuously maintained, which complies with cGMP， regulations and Sanofi global requirement.

执行和监督法规符合性相关工作，确保杭州工厂活动的法规符合性，并且符合现行GMP、法规要求及赛诺菲总部要求。

Activities具体职责

• 确保杭州工厂活动获得药品监管部门许可。维护和更新监管文件和数据库。 Ensure that the activities of Hangzhou site are approved by relative health authorities. Maintaining and updating regulatory files and databases.

• 维护杭州工厂药品生产许可证，包括及时组织到期换证、登记事项变更及许可事项变更申报等。负责申报策略制定、资料撰写及审批跟进等。

Maintain the drug production license of the Hangzhou factory, including organizing license renewal, managing variation of registration items and permission items, and etc. Responsible for the formulation of application strategies, dossier compiling and approval follow-up.

• 负责按照法规要求，定期进行必要的申报，维持杭州工厂GMP活动的符合性，例如定期申报中国GMP符合性检查、跟进欧盟GMP符合性检查安排等。

Responsible for making necessary declarations on a regular basis in accordance with regulatory requirements to maintain the compliance of GMP activities in Hangzhou, such as regularly apply for China GMP compliance inspections, following up EU GMP compliance inspection arrangements, etc.

• 确保工厂活动与注册资料的符合性。Ensure Regulatory Compliance with Registration Dossier.

• 负责收集和监控产品注册信息的变更（包括欧盟及中国注册产品的CCDS变更，行政信息变化等），组织实施变更。

Responsible for collecting and monitoring changes in product registration information (including CCDS changes, administrative information changes, etc.), and organizing the implementation of changes.

• 组织实施“法规符合性监测”项目。

Organize and implement the "Regulatory Compliance " project.

Review Quality Documents including Process Procedure, Product Specification and etc.

• 识别工厂产品和业务活动的变更可能带来的法规影响。

Defining the potential of changes made to the site products and services. 

• 负责变更控制的法规影响评估，制定法规申报策略并推进执行 （必要时，组织GRA， ICMC 及Affiliate共同处理）。

Responsible for the regulatory impact assessment of change control, the development of regulatory reporting strategy and the implementation of the regulatory declaration (if necessary, involve GRA, ICMC and Affiliate).

• 为工厂项目提供法规方面的专业支持，制定法规申报策略，确保符合法规要求。

Provide regulatory expertise for site projects, develop regulatory reporting strategies, and ensure compliance with regulatory requirements.

• 编写变更内容，包括受影响的CTD章节以及现场产品再注册等，确保符合所有适用法规和公司流程。Authoring the variations, the CTD sections impacted by the changes and the renewals of the site products registrations, in compliance with all applicable regulations and company processes.

• 与GRA对接，支持药品注册及注册变更相关工作，包括撰写注册文件中工厂活动相关的部分（年报，备案及补充申请），以及回复补正要求等。

Liaison with GRA to support drug registration and registration variations, including compiling registration dossier related to site activities (annual reports, filings and supplementary applications), and responding to requests for amendments.

• 监测杭州工厂产品注册状态，配合注册部及时进行再注册，确保产品注册状态有效。

Monitor the product registration status, and cooperate with the registration department to re-register in a timely manner to ensure that the product registration status is valid.

• 确保产品符合其对应市场中的所有相关产品注册要求、法律、法规、标准和指南。Ensuring compliance of the site products with all relevant product registrations, laws, regulations, standards, and guidelines in the markets where the site operates.

• 监控法规，指导原则（如ICH, 药典等）及其他发布信息的更新，进行必要的分析评估，确保按时合法执行。

Monitor evolution of regulations, guidelines (ICH, Pharmacopeias) and technologies and perform assessment to ensure on time implementation.

• 负责对员工进行法规要求的沟通及培训，提升员工合规意识。

Promotes and communicates the regulatory requirements to engage the colleagues in the compliance principle.

• 其他职责。 Other Responsibilities.

• 负责工厂场地主文件的维护与定期更新。

Responsible for the maintenance and regular updating of the site master file.

• 协助进行内部和外部审计，包括官方检查。

Assisting in internal and external audits, including regulatory inspections. 

• 组织精神药品管理，确保精神药品管理法规的有效执行。负责精神药品数据库的日常维护、年度计划上报、执行精神药品法规的定期培训及处理药品监管部门布置的相关工作等。

Organize the management of psychotropic drugs to ensure psychotropic drug management regulations are implemented in Hangzhou site. Responsible for daily maintenance of psychotropic drugs database, submission of annual plans, provide regular training of psychotropic drug management and related tasks assigned by Health Authority.

• 负责工厂与各级药品监管部门的对接：及时接收并处理各级药品监管部门对杭州工厂通知、问讯及工作安排等；按时上报药监部门要求的各类报告。

Act as focal point between site and Health Authorities at all levels: collect and timely process the notices, inquiries and work arrangements; submit report as per HA requirement.

• 其他赛诺菲集团质量文件中规定的该岗位负责的事项。

Other responsibilities as specified in the Sanofi Group's quality documents.

• 领导安排的其它工作。

Other work arranged by the leader.

• Be responsible for HSE in his/her position and job.
  对本岗位的职业健康安全环境工作负责。

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 5 years registration experience in pharmaceutical company, including experience with regulatory preparation of CMC dossier.
  工作经验: 至少5年以上制药行业的注册管理工作,包括CMC 资料撰写经验。
• Soft skill: Master to cGMP and regulation, Familiar to office software, Good communication and transversally cooperation.
  通用技能：精通现行GMP和法规，熟练应用办公电脑软件，良好的沟通协调能力。
• Technical skill:

In-depth understanding of regulatory requirements and guidelines relevant to the pharmaceutical industry. 对制药行业相关的监管要求和指南有深入的理解。

Ability to analyze complex regulatory documents and data to ensure compliance and identify potential issues. 能够分析复杂的监管文件和数据，以确保符合规定并识别潜在问题。

Proficiency in managing multiple regulatory projects simultaneously, ensuring timely submissions and compliance. 擅长同时管理多个法规项目，确保及时提交和合规性。

High level of accuracy and attention to detail in preparing and reviewing regulatory documents and reports. 在准备和审核监管文件及报告时，具有高度的准确性与注重细节的能力。

• Education: bachelor’s degree above, Pharmacy or related field
  教育背景: 本科学位以上，药学或相关专业。
• Languages: Good at English reading, writing, listening and speaking，be able to discuss the topics of quality and compliance in English fluently.
  语言要求: 良好的英语听、说、读、写能力，可以流畅的用英语探讨质量和合规相关的话题。

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Pursue Progress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, 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!