(Senior) Director* Global Regulatory Affairs - Diagnostics Regulatory Expert

  • Mainz
  • Work experience
  • Medicine, Pharmacy, Laboratory
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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.

(Senior) Director* Global Regulatory Affairs - Diagnostics Regulatory Expert

BioNTech is seeking a Diagnostics Regulatory Expert for Global Regulatory Affairs that can provide strategic and operational regulatory leadership across the pipeline for projects that require co-development and registration of an in-vitro diagnostic. This role will have the opportunity to break new ground in regulatory for several cutting-edge technologies such as liquid biopsies and in the context of highly innovative development program.
The Diagnostics Regulatory Expert will be accountable to work with the Global Regulatory Lead and Diagnostics Team to develop clinical assets and deliver marketing authorizations for our products globally.
Your main responsibilities are:
  • Act as Diagnostics Regulatory Expert as part of the Regulatory Sub-Team (RST) for the assigned development projects
  • In alignment with the Global Regulatory Lead (GRL) and BioNTech Diagnostics team, define and execute co-development diagnostic regulatory strategy (including but not limited to IUO, IVD and CDx) to support global clinical development objectives including post-market approvals and enable optimal market labeling for diagnostics; assess the diagnostic test needs for the companion medication and determine the strategy for the development and delivery of the diagnostic test for use in the clinical development program and for the product post-approval
  • Support the management and supervision of diagnostic vendors and development partners on behalf of BioNTech ensuring alignment between diagnostic development and clinical development objectives and timelines; serve as subject matter expert for BioNTech in the interface with IVD manufacturers and provide oversight as part of the established partnership governance
  • In partnership with the GRL, Diagnostic team, Clinical Development team, and third parties, lead the preparation of diagnostics-related regulatory submissions, including authoring, SME coordination and review of key regulatory documents
  • Plan, prepare and conduct interactions with Health Authorities (e.g. CDRH, EMA, Notified Bodies etc.) as appropriate in coordination with Legal Manufacturers in the scope of diagnostic development
  • Monitor regulatory and competitive landscape for diagnostics; analyze the impact of drug-device regulation changes for BioNTech's products; collect, evaluate and disseminate relevant updates as appropriate. Provide regulatory advice to all stakeholders in support of development
  • Build and modify existing processes and interfaces (internal and external) to continuously improve organizational efficiency

What you have to offer.

  • University degree, preferrably Master's, in a scientific discipline, added with at least 10 years of experience in regulatory affairs within the biotech or pharmaceutical industry, including experience interacting with CDRH
  • Significant experience and successful leadership in regulatory aspects of diagnostics development (IUO, IVD, CDx etc.)
  • Understanding of co-development involving complex diagnostic devices or diagnostic testing services based on biomarkers; experience with regulatory requirements for bridging studies and method comparison studies
  • Experience with EU and/or US regulatory device submissions, e.g. IDE, 510k, PMA etc.; good understanding of the EU IVDR, including relevant requirements and impact on diagnostics development and approval of companion diagnostics in the EU
  • Experience collaborating with vendors to support device development in alignment with clinical development programs, hands-on strategic and operational experience in co-development of in-vitro diagnostics and therapeutic products from early clinical phase to market approval  
  • Regulatory or scientific experience with anti-cancer immunotherapy, cell or nucleic-acid-based therapy, antibodies, or other advanced biologics is preferred.
  • Experience working with external medical/scientific experts to support development planning and strategy
  • Experience contributing to an oncology IND and NDA/BLA is preferred

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 4883 (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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