Associate Director* Global Regulatory Affairs - Development Projects

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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.

Associate Director* Global Regulatory Affairs - Development Projects

In this role, you will lead all aspects of Global Regulatory Affairs for several development projects. You will bring new medicinal products on the market. As you guide the products along this exciting path of product development, 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:
  • Function as global regulatory lead for assigned therapeutics and/or diagnostics in development and define and execute Regulatory Strategy from clinical development until marketing authorisation
  • Conduct interactions with national authorities and international agencies for example MPA, PEI, EMA, FDA and WHO in the scope of product development incl. market authorisation
  • Prepare / compile including review of regulatory documents/dossiers for product development and marketing authorisation
  • Supervision of vendors active in regulatory affairs on behalf of BioNTech
  • Regulatory Intelligence: Contribution and monitoring of changes and evolution in the regulatory landscape for therapeutics and/or diagnostics. Analyzing the impact of drug/devices changing regulations for BioNTech`s products

What you have to offer.

  • University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent)
  • At least 7 years of experience in relevant roles/positions
  • Experience in regulatory strategy planning and proven ability to plan, coordinate and lead activities
  • Experiences in the field of cell and gene therapy products preferable
  • Knowledge of multidisciplinary functions involved in drug development
  • Knowledge of clinical research and its application to drug development in therapeutic area of relevance such as Cancer and Infectious diseases
  • Very structured, accurate and team-oriented way of working
  • Business fluent English is a must

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 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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