Director* Global Regulatory Affairs

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

Director* Global Regulatory Affairs

BioNTech provides you the opportunity to contribute to the development of cutting-edge therapies for cancer and other serious diseases fulfilling patients' unmet medical needs. In your role as Strategist Global Regulatory Affairs you will support the development and life cycle management of BioNTech's novel pharmaceutical products on their way to market and beyond. In cooperation with the Vice President for Global Regulatory Project Management and BioNTech's Management Board, you will lead the regulatory strategy of several investigational compounds.  Your main responsibilities are:
  • Elaborate regulatory strategies for assigned projects, including product development plans, clinical trials and marketing authorizations of therapeutics
  • Conduct interactions with national European-competent authorities and international agencies such as EMA and FDA in the scope of product development and marketing authorization
  • Represent Regulatory Affairs in multidisciplinary and global development teams providing guidance and strategy
  • Contribute to the preparation and compilation of regulatory documents such as scientific advice briefing documents, clinical trial applications and marketing authorization dossiers
  • Act as regulatory contact person for several stakeholders
  • Monitor changes and evolution of the global regulatory landscape for medicinal products and analyze the impact of these changing regulations for BioNTech's product pipeline (Regulatory Intelligence)

What you have to offer.

  • University degree in natural sciences (medicine, pharmacy, [bio-] chemistry, biotechnology or [molecular] biology)
  • Minimum of 7 years of professional experience in the development of (bio-) pharmaceutical products in various development phases (at least early stage)
  • At least 5 years of experience in Drug Regulatory Affairs including sound knowledge of regulatory requirements and procedures in at least 2 regions: EU/EEA (including Germany) and US
  • Experiences in regulatory strategy planning and proven ability to plan, coordinate and lead activities simultaneously on multiple projects
  • Experiences in the field of advanced therapy medicinal products especially gene therapy medicinal products preferable
  • Sound knowledge of clinical cancer research and its application to cancer drug development or analogue experience in a specialty therapeutic area of relevance
  • Very structured, accurate and team-oriented way of working
  • Business fluent English is a must; good German skills are advantageous

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 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

https://biontech.de