Senior Manager, Global Regulatory Affairs - Submission & Publishing APAC (Beijing, BJ, CN, 100027)

Beijing, China   |   full time   |   Job ID: 11588

About the role:

As a Senior Manager in Global Regulatory Operations, you will play a pivotal role in driving BioNTech’s mission to revolutionize medicine by ensuring timely and compliant regulatory submissions for the APAC region. Your expertise will contribute directly to our success in clinical development, marketing authorization, and post-approval life-cycle activities. You will be part of a dynamic team where collaboration and innovation thrive, helping shape processes and systems that enhance operational efficiency.

In this role, you will have the opportunity to work closely with regional and global stakeholders, leveraging your knowledge of APAC-specific regulatory requirements. This is more than just a job, it’s a chance to influence how we deliver groundbreaking therapies to patients worldwide.

Your contribution:

Compile and publish regulatory dossiers for APAC Health Authorities, ensuring timely submissions aligned with BioNTech standards

Act as Subject Matter Expert for APAC pre- and post-marketing submissions, staying updated on regional regulatory changes

Contribute to the setup, implementation, and continuous improvement of systems and processes for GRO activities in the APAC region

Build effective cross-functional relationships with regional and global stakeholders to align objectives and ensure transparency

Support knowledge transfer within the team by guiding colleagues and contributing to their development

Provide cross-regional support for Europe and US regulatory publishing activities as needed

A good match:

University degree in technical, scientific, or pharmaceutical fields with over 5 years of relevant professional experience

Proven track record in publishing regulatory submissions, including eCTD submissions for APAC clinical development, marketing authorization, and post-approval life-cycle activities

Fluency in spoken and written Mandarin and English

High attention to detail coupled with excellent organizational skills to meet tight deadlines

Ability to work independently while effectively managing priorities within agreed timelines

Experience guiding teams or colleagues in regulatory publishing is desirable

Open-mindedness, flexibility, and a willingness to learn while demonstrating sound judgment

Your benefits:

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

We are looking forward receiving your application.

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