Director* Global Regulatory Affairs CMC

  • Mainz
  • Work experience
  • Research, development, teaching
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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.

Director* Global Regulatory Affairs CMC

You will lead all aspects of Regulatory Affairs CMC of Investigational Medicinal Products in clinical development. You will bring new medicinal products on the market. And as you guide the products along this exciting path, you will establish new regulatory paths and define requirements for these next generation of therapeutics and vaccines. In your role, you will act globally and work cross-functionally.

Your duties in detail:
  • Define and execute regulatory CMC strategy for Investigational Medicinal Products in clinical development including registration. The strategy needs to be aligned continuously with product development plan and the CMC development.
  • Responsible for all regulatory CMC activities during product development from early clinical stage up to registration
  • Responsible for all regulatory CMC activities during maintenance of Marketing Authorisation(s) including life cycle management
  • Responsible for regulatory CMC content of regulatory application and dossiers, which includes coordination of preparation, writing and reviewing of documents and dossiers
  • Identify critical Regulatory CMC development issues and proactively implement activities for their resolution

What you have to offer.

  • Degree in pharmacy, chemistry, biology, biochemistry, or equivalent
  • 6 years professional working experience in Regulatory Affairs CMC globally during clinical, registration and/or post-marketing for Biologics, Vaccines and Small Molecules
  • Extensive experience in preparation and revision of regulatory CMC documents
  • Knowledge of CMC drug development (Drug Substance and Drug Product) and knowledge of multidisciplinary functions involved in drug development and manufacturing
  • Result-and goal-oriented
  • Excellent communication skills in English

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, 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 4202 (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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https://biontech.de