Director* Regulatory Affairs CMC

  • Mainz
  • Senior, very experienced
  • Manager First Level
  • Executive Middle Management
  • Production, manufacturing
  • Quality Management, Quality Assurance

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.

Director* Regulatory Affairs CMC

At BioNTech, you will be responsible for leading the day-to-day CMC Regulatory Affairs operations to include managing a global team as well as building/driving strategy and regulatory/compliance filings. Your primary responsibilities in detail:
  • Strategic development and optimization of the Regulatory Affairs CMC team, including the respective processes/procedures/SOPs for market approval (Phase I to Phase IV)
  • Strategic planning of the Regulatory Affairs CMC activities for all clinical projects at BioNTech (i.e., mRNA, antibodies, CARs, small molecules)
  • Regulatory evaluation of CMC development activities and data
  • Oversight of regulatory dossiers (e.g., creation; modification; submission) for market approval and beyond
  • Lead, manage, develop, mentor and hire global team members

What you have to offer.

  • Scientific degree is highly preferred, along with at least 10 years of relevant academic/government/CRO/industry experience
  • A minimum of 5 years of direct CMC regulatory experience, to include a global background, is required
  • Significant management and leadership background is required
  • Significant experience working with national agencies in Europe as well as EMA and FDA is required; Further regions (Japan, China, Rest of World (RoW)) is preferred
  • Experience managing and overseeing of regulatory documents/dossiers for market approval and beyond is required
  • Experience with biologics and drug development is required; Gene and/or cell therapies experience is preferred
  • Adaptability, strategic mindset, innovative yet pragmatic/solution-oriented thinking, and attention to detail with a strong orientation to quality required
  • Fluent English language skills and professional-level communication skills (i.e., oral, written, presentation) required
  • Willingness to travel locally, regionally and internationally

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, Andy Wingstrom 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