Director Global Regulatory Affairs CMC

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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 CMC

You will lead all aspects of Regulatory Affairs CMC throughout clinical development up to commercial lifecycle of innovative products. 

Your main responsibilities are:
  • Lead the development, implementation, and execution of regulatory CMC strategy 
  • Ensure all regulatory submissions and CMC projects align with defined regulatory strategy and proactively identify gaps, work with cross-functional teams to develop mitigation proposals
  • Lead and manage preparation of high-quality regulatory submission content of the CMC sections to support global clinical development and registration
  • Represent regulatory CMC in global multi-disciplinary meetings/forums that require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance and achievement of regulatory department and program objectives 
  • Participate in regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
  • Ensure that program team colleagues, line management, and partners are informed of developments that may affect regulatory success
  • Manage regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments on deviations, CAPAs, change controls, etc.

What you have to offer.

  • Degree in pharmacy, chemistry, biology, biochemistry, or equivalent
  • 9+ years professional experience in Global Regulatory Affairs CMC during clinical, registration for Biologics, Vaccines and/or Small Molecules
  • Extensive experience in preparation and life-cycle management of regulatory CMC documents to support clinical trial applications (IMPD, IND) and marketing authorizations  (BLA, MAA)
  • Knowledge of CMC drug development (Drug Substance and Drug Product) and knowledge of multidisciplinary functions involved in drug development and manufacturing
  • Good combination of strategic and operational skills; ability to make flexible, but thorough decisions in a highly dynamic environment
  • 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 Cambridge, Massachusetts, 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 7587 (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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