VP* Global Regulatory Affairs CMC Lead

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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.

VP* Global Regulatory Affairs CMC Lead

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 main responsibilities are:
  • Define and establish – internal and external – overarching-platform approaches across the product types in development and maintenance. Supervise Product Type leads in defining requirements for accelerated development path toward marketing authorisation for the respective product type.
  • Supervise the design and execution of Regulatory CMC Strategy of i) key development projects towards global marketing authorisation across all product types, including aspects of co-developed of a companion diagnostic /device where relevant and ii) commercial products in post-marketing phase across all product types.
  • Define strategy for interactions with national authorities and sovra-national regulatory agencies in the scope of CMC aspects for IMPs and commercial products for key products and platforms.
  • Define strategy and processes for harmonized regulatory CMC dossiers across the product types. Ensure transfer of knowledge in development across the product types and facilitate harmonisation of regulatory CMC strategies and processes throughout BioNTech pipeline.
  • Leading and developing the product type team leads such as lead of Cell Therapy, iNeST etc. Ensure education and training of product type leads to guarantee that experiences and know-how is available to meet requirements from the projects and development stages. Involvement of external expertise as needed in developments and maintenance.

What you have to offer.

  • Degree in pharmacy, chemistry, biology, biochemistry, or equivalent
  • Many 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 6982 (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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