Manager *Global Regulatory Affairs

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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 *Global Regulatory Affairs

You will support the Global Regulatory Affairs Development Pipeline team in the planning and execution of defined regulatory activities required for managing clinical trials and product development from a regulatory perspective. In your role, you will act globally and work cross-functionally.

Your main responsibilities are:
  • Support and/or attend Project Core Team meetings and regulatory subteam meetings for the assigned projects as global regulatory affairs delegate
  • Establish and maintain proper regulatory processes for the regulatory handling and lifecycling of clinical trials worldwide, in alignment with Global Regulatory Operations and Clinical Research
  • Organizations as appropriate, to ensure regulatory documentation is properly maintained according to internal SOPs, regulatory requirements and best practice
  • Manage the regulatory submission process from preparation phase to approval, oversee maintenance of a repository of regulatory documentation according to internal procedure and best practices
  • Work with (Sr) Directors on definition of the regulatory strategy for the assigned projects, provide input to the relevant development plans as needed
  • Review of protocols, reports and all types of regulatory documentation (quality, safety, efficacy, and labeling), including CTAs and INDs

What you have to offer.

  • Degree in pharmacy, chemistry, biology, biochemistry, medicine or equivalent
  • At least 3 years professional working experience in Regulatory Affairs within a clinical trial setting
  • Experience in preparation and revision of Marketing Authorisation Dossiers, scientific advices and US and EU designation applications is a plus
  • Basic knowledge of regulatory requirements and procedures in the EU/EEA and US throughout the product’s life cycle
  • Knowledge of multidisciplinary functions involved in clinical trials and pharmaceutical development
  • 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  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 7614 (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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