Manager, Regulatory Affairs (Shanghai, SH, CN, 200050)
About this opportunity
Shanghai, China | full time | Job ID: 11816
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
Inspired? Join our team of pioneers and bright, open minds. From our founders to our
scientists to our business professionals, we think out-the-box, believe in ourselves, work agile and stand accountable.
Together, we usher in a new era of immunotherapies and work on realizing our vision.
Do you have any questions?
Please contact Jenny Yao (Talent Acquisition) or jobs@biontech.de with reference to the job ID.
BioNTech, our story.
At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to
revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide,
especially by addressing diseases with high medical needs like cancer and various infectious diseases.
Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop
business strategies driven by our shared passion for advancing medicine.
Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and
become part of a mission that has the potential to change lives around the world.
BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality,
ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status.
We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 234 comparable Manager Regulatory Affairs roles across 73 biopharma companies.
Salary context
69 of 234 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 234 comparable roles
+ 22 more countries
Seniority mix
234 of 234 peers have a known seniority level
Therapeutic area mix
20 of 234 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
Or follow a whole field: get every new Regulatory Affairs job in Saint Helena, Ascension and Tristan da Cunha, and choose locations and companies.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.