Manager* Global Regulatory Affairs

  • Mainz
  • Work experience
  • Medicine, Pharmacy, Laboratory
  • Research, development, teaching
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Become a member of the BioNTech Family!

As a part of our team of more than 1.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age: Amongst multiple programs in the pipeline, we are conducting research on a Covid-19 vaccine in our project “Lightspeed” based on our mRNA-technologies. Furthermore, we are pioneers in the development of individualized cancer therapies and in the combat against other diseases.
 
We aim to achieve life-changing successes for patients by being innovative, passionate and united,so 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* Global Regulatory Affairs

BioNTech provides you the opportunity to contribute to the development of cutting-edge therapies for cancer and other serious diseases fulfilling patients' unmet medical needs. In your role as Manager Global Regulatory Affairs, you will support the development and life cycle management of BioNTech's novel pharmaceutical products on their way to market and beyond. Your main responsibilities are:
  • Conduct interactions with national authorities and international agencies such as EMA and FDA in the scope of product development and marketing authorization
  • Prepare and submit regulatory dossiers for clinical trial applications
  • Support regulatory activities in preparation of marketing authorizations incl. compilation of marketing authorization dossiers for e.g. MAA/BLA
  • Monitor changes and evolution of the regulatory landscape for both drugs and medicinal devices; analyze the impact of these changing regulations for BioNTech's products (Regulatory Intelligence)

What you have to offer.

  • University degree in natural sciences (pharmacy, [bio-] chemistry, biotechnology or [molecular] biology) or medicine
  • Profound knowledge and experience in relevant legislation and international guidelines (EMA, FDA; ICH) relevant for overall pharmaceutical development
  • Experiences in regulatory affairs requirements and procedures in in at least 2 regions: EU/EEA (including Germany) and US
  • Sound knowledge of clinical cancer research and its application to cancer drug development or analogue experience in a specialty therapeutic area of relevance
  • Organizational talent, structured and solution-oriented way of working as well as analytical and conceptual skills
  • Experience with Advanced Therapeutic Medicinal Products, with RNA and/or with lipid-formulated products are a plus
  • Fluent in English (spoken and written); German is a plus

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 Mainz and simply send us your application documents using our online form.

If you have any further questions, Johanna Diehl will be happy to answer them on + 49 (0) 6131-9084-1291 (Monday - Friday, from 12 noon).

*BioNTech does not differentiate on the basis of gender, race, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.

BioNTech - As unique as you

https://biontech.de