Director* Global Regulatory Affairs Global Labeling 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.

Director* Global Regulatory Affairs Global Labeling Lead

You will be member of the Global Regulatory Affairs - Commercial Portfolio team and will lead all regulatory activities required for maintenance of product informative texts ("labels") for commercial products during life cycle maintenance of marketing authorisations globally. In your role, you will act globally and work cross-functionally.
Your main responsibilities are:
  • Define and execute labeling strategy for global life cycle management of product authorised medicinal products in BioNTech's responsibility. The strategy comprises management of local markets label dependencies and country label differences
  • Build and lead a global labeling team
  • Responsible for timely submission of label updates following update of the company’s Core Data Sheet (CCDS) or on request of competent Health Authorities
  • Ensuring timely implementation of updated CCDS content into the local labels of MAs in BioNTech’s responsibility
  • Responsible for regulatory processes and systems applied for global label updates
  • Identify critical Regulatory issues and proactively implement activities for their resolution

What you have to offer.

  • Degree in pharmacy, chemistry, biology, biochemistry, medicine or equivalent
  • Many years professional working experience in Regulatory Affairs globally during development, registration and/or post-marketing for Biologics, Vaccines and/or Small Molecules, including direct experience in labeling management and dealing with health authorities
  • Profound experience in leading the preparation and revision of product informative texts during registration and/or post-marketing, at least for EU/EEA and US
  • In depth knowledge of EMA and FDA regulatory requirements for product informative texts
  • Knowledge of multidisciplinary functions involved in global label update processes
  • 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 6984 (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!

BioNTech - As unique as you

https://biontech.de