Senior Director* Global Regulatory Affairs Regulatory Operations

Mainz, Germany

Job Description

Work experience
Medicine, Pharmacy, Laboratory
Research, development, teaching

Become a member of the BioNTech Family!

As a part of our team of more than 1.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age: Amongst multiple programs in the pipeline, we are conducting research on a Covid-19 vaccine in our project “Lightspeed” based on our mRNA-technologies. Furthermore, we are pioneers in the development of individualized cancer therapies and in the combat against other diseases.

We aim to achieve life-changing successes for patients by being innovative, passionate and united,so 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.

Senior Director* Global Regulatory Affairs Regulatory Operations

You will lead all Regulatory Operations activities enable and support BioNTech´s Investigation Medicinal Products, Companion Diagnostics and the Commercial Portfolio. You will bring new medicinal products and diagnostics on the market. In your role, you will act globally and work cross-functionally. Your main responsibilities are:
  • Supervise and oversee all internal and external Regulatory Operations activities required to enable and support global clinical development activities towards marketing authorisation across all IMPs and diagnostics in development.
  • Supervise and conduct compilation, publishing, submissions (dispatch) of regulatory documents, amendments and dossiers to competent authorities. Establish and maintain internal expertise on technical requirements for regulatory submissions.
  • Oversight and maintenance of marketing authorisation dossiers worldwide including harmonization of global dossiers through lifecycle management.
  • Establish the regulatory operations sub-team including technical expertise, which is responsible planning and executing regulatory operations activities in the scope of product development and market authorisations.
  • Set-up, update/maintain processes and systems required for regulatory operations in the scope of product development and market authorisation.

What you have to offer.

  • Degree in pharmacy, chemistry, biology, biochemistry, medicine or equivalent
  • 12 years professional working experience in global Regulatory Operations / Regulatory Informatics
  • Extensive experience in management of dossier for investigational and marketed products and submission management including electronic publishing
  • Profound Knowledge of regulatory requirements and procedures in the EU/EEA and US throughout products life cycle
  • Profound Knowledge of regulatory information management including technical requirements and systems used in regulatory operations such as document management systems
  • 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, Johanna Constanze 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!

BioNTech - As unique as you

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Job Detail

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    Mainz, Germany
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