Beijing Manager, Regulatory Affairs BJ 100020

Job description

北京，中国 | 全职 | Job ID: 11815 About the Role: At BioNTech, we are more than a biotechnology company – we are a community of innovators dedicated to revolutionizing medicine through cutting-edge science. As a Manager in Regulatory Affairs , you will play a pivotal role in ensuring our products meet regulatory requirements across the APAC region. Your expertise will directly contribute to our mission of improving health worldwide by addressing diseases with high medical needs like cancer and infectious diseases. In this role, you will join a dynamic team within Global Regulatory Affairs, fostering innovation and collaboration while advancing BioNTech’s diverse portfolio of product candidates. If you’re passionate about shaping the future of medicine, this position offers an opportunity to grow your career and make a meaningful impact. Your Contribution: Support the APAC Regulatory Lead in executing regulatory strategies for development projects from clinical development through marketing authorization and lifecycle management Coordinate APAC regulatory activities, including health authority interactions, dossier preparation, and timely submissions while ensuring compliant documentation Prepare and conduct interactions with regulatory agencies in the APAC region, managing documentation such as meeting minutes and correspondence Collaborate with internal stakeholders and external vendors to optimize regulatory processes, systems, and interfaces Monitor changes in the APAC regulatory landscape, assessing impacts on BioNTech products and communicating recommendations effectively Contribute to continuous improvement initiatives within Global Regulatory Affairs A Good Match: University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent) At least 3 years of professional experience in Regulatory Affairs with responsibility for countries in the APAC region Familiarity with regulatory activities throughout drug development and/or lifecycle management (INDs, marketing authorization applications, variation applications) Business fluency in English and Chinese (written & spoken) with strong communication skills Ability to manage multiple priorities effectively in a fast-paced environment while ensuring high-quality documentation Knowledge of the Chinese and broader APAC pharmaceutical/biotechnology regulatory landscape BioNTech 重视每一位团队成员的福祉，为多元化的员工提供全面的福利保障。我们提供具有市场竞争力的薪酬方案，具体将根据职位、工作地点及候选人资历与经验综合确定。注：各项福利的实际适用范围、享有条件及具体内容可能因所在地而异，最终以公司内部政策及当地法律法规为准。 申请方式： 请通过我们的在线申请链接提交以下材料： 个人简历 学位证书及职业资格证书复印件 联系方式 重要提示： 我们仅接受通过链接在线提交的求职申请。 提交申请即视为您知悉，招聘流程中将依相关法律法规进行背景调查。如您进入候选名单，BioNTech 将通过合作服务机构“HireRight”开展背景调查工作，招聘专员将及时与您沟通具体安排。 我们诚挚期待您的加入。 立即申请 » 查找类似职位: Alle Stellen, All Jobs Terms of Use General Terms and Conditions Data Privacy Statement Imprint Cookie Settings © 2024 BioNTech SE. All rights reserved Cookie 许可管理器 当您访问任何网站时，它可能存储或检索浏览器中的信息，大多数为 cookie 形式。我们尊重您的隐私权，因此您可以选择不允许某些类型的 cookie。但是，阻止某些类型的 cookie 可能影响您的网站体验以及我们能够提供的服务。 需要的 Cookie 需要这些 cookie 才能使用此网站，无法将其关闭。 需要的 Cookie 需要的 Cookie 提供者 描述 已启用 SAP as service provider 我们使用以下会话 cookie，使网站正常工作需要所有这些 cookie： "route" 用于会话粘性 "careerSiteCompanyId" 用于将请求发送至正确的数据中心 "JSESSIONID" 在会话期间位于访问者的设备上，以便服务器能够识别访问者 "Load balancer cookie"（实际的 cookie 名称可能不同）阻止访问者从一个实例跳转到另一个实例 需要来自提供者 SAPasserviceprovider 的 cookie，无法将其关闭 功能 Cookie 这些 cookie 可以通过记住您的登录详细信息、优化视频性能或提供有关如何使用网站的信息来在此网站上提供更好的客户体验。您可以随时自由选择接受或拒绝这些 cookie。请注意，如果您不接受这些 cookie，这些第三方提供的某些功能可能受影响。 同意所有 功能 Cookie 功能 Cookie 提供者 描述 已启用 YouTube YouTube 是一项视频共享服务，用户在此可以创建自己的档案，上传视频，以及观看、点赞和评论视频。选择拒绝 YouTube cookie 将无法观看 YouTube 视频或与其交互。 Cookie 政策 隐私政策 条款和条件 同意来自提供者 YouTube 的 cookie