Manager*/Associate Director* Global Regulatory Affairs Commercial Portfolio

  • Mainz
  • 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.

Manager*/Associate Director* Global Regulatory Affairs Commercial Portfolio

You will be member of the Global Regulatory Affairs - Commercial Portfolio team and will lead execution of defined regulatory strategy for commercial products required for life cycle maintenance of marketing authorisations globally. In your role, you will act globally and work cross-functionally.

Your main responsibilities are:
  • Support definition and execution of global regulatory strategy for commercial products, including maintenance of Marketing Authorisation(s) and drug life cycle management. The strategy needs to consider requirements and regulatory commitments, as well as ensure continued alignment with market needs and the further product development post-marketing. 
  • Responsible for defined regulatory activities starting from initial marketing authorization preparation and continuing through all post-registration activities, which including matters from clinical, medical, Pharmacovilance and labelling. Regulatory activities might involve cooperation with partner for outsourcing or co-developing.
  • Responsible for defined Marketing Authorisation(s) dossiers, which includes coordination of preparation, update, writing and reviewing of documents and dossiers.
  • Support of definition of regulatory processes and systems applied for maintenance of Marketing Authorisation(s) and drug life cycle management.
  • Report any observed critical Regulatory issues and proactively implement activities for their resolution.

 

What you have to offer.

  • Degree in pharmacy, chemistry, biology, biochemistry, medicine or equivalent
  • At least 5 years professional working experience in Regulatory Affairs globally during registration and/or post-marketing for Biologics, Vaccines and/or Small Molecules
  • Profound experience in preparation and revision of Marketing Authorisation Dossiers
  • Knowledge of regulatory requirements and procedures in the EU/EEA and US throughout products life cycle
  • Knowledge of multidisciplinary functions involved in registration process and maintenance phase
  • 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.
We are able to offer you this position as an Associate Director with appropriate work experience.

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 4345 (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