(Senior) Manager* Regulatory Affairs CMC

  • 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 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.

(Senior) Manager* Regulatory Affairs CMC

You will lead all aspects of Regulatory Affairs CMC for Investigational Medicinal Products in a clinical program and bring new medicinal products on the market. As you guide the products along this exciting path, you will establish new regulatory routes and define requirements for these next generation of therapeutics and vaccines. In your role, you will act globally and work cross-functionally. Your main responsibilities are:
  • 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 Authorization(s) including life cycle management
  • Preparation, writing and reviewing of CMC documentation in the context of marketing authorisation dossiers (MAA, BLA) as well as dossiers for clinical investigational medicinal products.
  • Preparation, writing and reviewing of briefing packages and participation in scientific advice meetings with various regulatory authorities
  • Responsible for regulatory advice and compliance

What you have to offer.

  • Degree in pharmacy, chemistry, biology, biochemistry, or equivalent
  • Several years of professional experience in regulatory affairs CMC
  • Solid experience in preparation, revision and maintenance of regulatory CMC documents for clinical trial approvals (IMPD, IND) and marketing authorisations (BLA, MAA)
  • Extensive knowledge in CMC drug development, preferred ATMPs and/or vaccines
  • Very good knowledge of the relevant laws and guidelines as well as experience in the implementation and optimisation of processes, CMC-relevant databases and data management systems  
  • 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 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 3492 (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