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