(Senior) Legal Counsel* Pharmaceutical Regulation

  • Mainz
  • Work experience
  • Law
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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) Legal Counsel* Pharmaceutical Regulation

As a (Senior) Legal Counsel, you provide legal advice to the BioNTech group, including executive officers and other internal departments, with a focus on the application and interpretation of pharmaceutical regulations and their impact on business activities. Your main responsibilities are:
  • Collaborate with the Regulatory Affairs team to craft the company’s regulatory strategies for obtaining special pharmaceutical designations, accessing accelerated approval pathways, and obtaining marketing authorizations and regulatory exclusivity
  • Provide expert, on-demand advice to the clinical, manufacturing and commercial teams regarding pharmaceutical laws and regulations 
  • Liaise with Intellectual Property (IP) and Regulatory Affairs teams to coordinate a comprehensive assessment of global IP and regulatory exclusivities strategy
  • Support the Public Affairs team by providing legal advice to inform and shape advocacy before FDA, EMA and other governmental bodies and agencies
  • Provide legal advice to support corporate transactions, such as supporting due diligence exercises for M&A and collaboration activities
  • Manage and provide strategic guidance for product liability claims and litigation matters, including review of pleadings, discovery responses and other court filings, risk assessment and settlement negotiations

What you have to offer.

  • Graduate and a qualified lawyer with the ability to analyze complex legal issues and with several years of working experience in a pharmaceutical regulatory department of a law firm or a pharmaceutical company
  • Detailed knowledge of current European pharmaceutical laws and regulations, a good understanding of pharmaceutical laws and regulations in the US is beneficial  
  • Experience in representing a pharmaceutical company in its interactions with external stakeholders including government bodies and agency officials (e.g. FDA, EMA) 
  • Strong verbal and written communication skills together with a high ability to influence and negotiate added will a fluency in English, the ability to read and speak German is beneficial
  • Supportive interpersonal team player, talented at collaborating cross-functionally

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, Margarita Hoffmann 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, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.

BioNTech - As unique as you

https://biontech.de