Job title职位名称: Regulatory Site Officer 法规主管
• Location工作地点： Beijing北京
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-BEI 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：
• · Ensuring compliance of a group of products with all relevant product registrations, laws, regulations, standards, and guidelines in the markets where the site operates. 确保一组产品符合公司运营所在市场的所有相关产品注册要求、法律、法规、标准和指导原则。 · Authoring the variations, the CTD sections impacted by the changes and the renewals of a group of products registrations, in compliance with all applicable regulations and company processes. 按照所有适用法规和公司流程,负责起草一组产品注册的变更申请、受变更影响的CTD(通用技术文件)章节以及再注册文件。 · Ensuring accurate and timely documentation of regulatory activities. 确保监管事务活动的文档记录准确及时。 · Overseeing regulatory aspects of product lifecycle management. 监督一组产品全生命周期管理中的监管事务。 · Define the potential regulatory impacts of changes made to a group of products and services. 明确对一组产品和服务所做变更可能产生的潜在监管影响。 · Monitoring and anticipating changes in the regulatory environment and determining the impact and implications for the site of a group of products. 监测和预判监管环境的变化,并判断其对该组产品所在工厂的影响和意义。 · Participating in regulatory inspections and audits, providing regulatory support and documentation. 参与监管检查和审计,提供监管支持和相关文档。 · Managing and training regulatory site officers (RSO). 管理并培训工厂法规专员(RSO)。
About you 任职资格: Master's degree or higher in Pharmaceutical Sciences, Biology or a related discipline. 拥有药学、生物学或相关学科的硕士或更高学位。 3 years of experience in regulatory affairs within the pharmaceutical industry, including preparation and submission of regulatory documents. 拥有3年以上制药行业监管事务经验，包括法规文件的准备和提交。 In-depth understanding of regulatory requirements, guidelines, and processes within the pharmaceutical industry. 深入了解制药行业的监管要求、指南和流程。 Strong project management skills to handle multiple regulatory projects and ensure timely submissions and compliance. 具备强大的项目管理能力，能够处理多个监管项目，确保及时提交和合规。 Excellent analytical skills to interpret regulatory changes, assess their impact, and develop appropriate strategies. 具备出色的分析能力，能够解读监管变更、评估其影响并制定合适策略。 Effective communication skills to liaise with regulatory agencies, internal teams, and other stakeholders. 具备与监管机构、内部团队及其他利益相关者沟通的有效沟通能力。 High level of attention to detail to ensure accuracy in regulatory documentation and compliance activities. 高度注重细节，确保监管文件和合规活动的准确性。 Languages: Fluent English in verbal & written. 语言要求: 熟练的英语书写及沟通能力。 Take the Lead: Aim Higher, Act for Patients, Be Bold, Lead Together . 敢为人先: 志存高远，心系患者，敢于创新，聚力同行。
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!
Pursue progress, discover extraordinary 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, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!