Manager, Regulatory Affairs

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。