Manager* Regulatory Affairs CMC

  • BioNTech Careers
  • Mainz
  • Work experience
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Become a member of the BioNTech Family!

As a part of our team of more than 2.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Manager*Regulatory Affairs CMC

You will be responsible for all aspects of Regulatory Affairs CMC for the lifecycle of commercial innovative products.

Your main responsibilities are:
  • Support execution of the global regulatory CMC strategy for assigned commercial products
  • Ensure all regulatory submissions and CMC projects align with defined regulatory strategy and proactively identify gaps, work with cross-functional teams to develop mitigation proposals
  • Manage regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments on deviations, CAPAs, change controls, etc.; Monitor compliance to regulatory requirements and commitments
  • Represent regulatory CMC in global multi-disciplinary meetings/forums that require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance, Internal regulatory consultancy for different stakeholders

What you have to offer.

  • Degree in pharmacy, chemistry, biology, biochemistry, or equivalent
  • 3+ years professional experience in regulatory affairs CMC for lifecycle maintenance of Biologics, Vaccines and/or Small Molecules
  • Solid experience in preparation and life-cycle management of regulatory CMC documents to support variations/amendments as well as marketing authorizations (BLA, MAA)
  • Extensive knowledge of product life cycle management and CMC drug development
  • Very good knowledge of the relevant laws and guidelines
  • Organisational talent, analytical and conceptual skills as well as excellent communication skills in English (written and spoken)

Benefits for you.

  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more.

Have we kindled your pioneering spirit?

Then apply now for our location  and simply send us your application documents using our online form.

If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).

Job-ID 8027 (please indicate for inquiries)

We look forward to your application!

*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!

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