Specialist, Regulatory Affairs (Beijing, BJ, CN, 100020)

北京，中国   |   全职   |   Job ID: 11879

About the role:

As a Specialist in Regulatory Affairs, you’ll support regulatory activities across the Asia-Pacific region by preparing submission documentation, coordinating regulatory interactions and tracking key activities. Your work helps BioNTech advance its mission by supporting the regulatory pathways for its therapeutics.

You’ll collaborate with the APAC regulatory lead, colleagues across functions and local partners. You’ll also help improve regulatory processes and assess relevant changes in the regional regulatory landscape.

Your contribution:

Prepare and maintain accurate submission documents in collaboration with the APAC regulatory lead and relevant stakeholders

Coordinate requests from local regulatory partners with the appropriate APAC team members

Support regulatory interactions, including the preparation of responses to agency inquiries

Track regulatory activities and maintain regulatory status and planning data in relevant databases

Improve regulatory processes, systems and interfaces, and coordinate with external vendors

Monitor APAC regulatory developments and help assess their potential impact on BioNTech products

A good match:

Vocational training or a university degree in a technical, business or natural sciences field, or equivalent experience in healthcare or pharmaceuticals

Experience in Regulatory Affairs with responsibility for countries in the Asia-Pacific region

Working knowledge of Chinese and broader Asia-Pacific regulatory requirements for pharmaceutical or biotechnology products is an advantage

Proficiency in written and spoken English and Chinese

Strong organizational skills and attention to detail, with a commitment to accurate documentation

Ability to collaborate across global, cross-functional teams, coordinate with external partners and adapt to changing priorities

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我们诚挚期待您的加入。