Specialist, Regulatory Affairs

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 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。