Director Regulatory Affairs CMC

Open for hire at one of the following locations – London, Mainz Goldgrube .

Become a member of the BioNTech Family!

As a part of our team of more than 5.000 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 Regulatory Affairs CMC

Through your innovation, passion and unity with your colleagues you can become a pioneer in our Global Regulatory Affairs Team.

In this position, you will lead all aspects of Global Regulatory Affairs CMC for Investigational Medicinal Products: Antibody-Drug Conjugate (ADC)/Monoclonal Antibodies (mAb) in a clinical program in order to bring new medicinal products on the market.

As you guide the products along this exciting path, you will establish new regulatory routes and define requirements for these next generations of therapeutics. You will also get the opportunity to act globally and work cross-functionally.

Your main responsibilities are:

• Act as global regulatory affairs CMC lead for assigned development and/or commercial products/projects. Define and execute the Global Regulatory CMC strategy from pre-clinical stage up to Marketing Authorisation and/or life cycle maintenance
• Define the strategy of the interactions with national authorities and sovra-national regulatory agencies in the scope of CMC aspects for the assigned products. Plan, prepare and conduct all CMC related topics/aspects for the interactions in the scope of products under development up to Marketing Authorisation and/or in the life cycle
• Define the regulatory CMC dossiers strategy, content and appropriateness for the respective development and commercial products (lifecycle maintenance); coordinate the preparation and author (e.g. briefing books, CMC sections in the IB) and review the regulatory CMC submission packages including source documents
• Implement and apply as well as adjust and continuously optimize harmonized regulatory CMC processes and systems. Collaborate with internal and external stakeholder using regulatory CMC standards and processes
• Regulatory Intelligence: Monitor changes and evolution in the regulatory CMC landscape for medicinal products and analyze the impact of changing regulations on BioNTech´s products and/or assigned projects
  
  

What you have to offer:

• Degree in pharmacy, chemistry, biology, biochemistry, or equivalent
• At least 9 years professional experience in Global Regulatory Affairs CMC during clinical, registration and/or post-marketing for Biologics and/or Vaccines and Small Molecules
• Extensive experience in preparation and revision of regulatory CMC documents
• 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 and German
  
  

Benefits for you:

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits supporting our diverse employee base. We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.

Please click the link below to review a highlight of our benefits -

https://www.biontech.com/int/en/home/careers/working-at-biontech.html

Have we kindled your pioneering spirit?

This vacancy is to be hired at one of the following locations – London, Mainz Goldgrube . Apply now for your preferred locations and simply send us your application documents using our online form.

• BioNTech does not differentiate on the basis of gender, political opinion, religion or belief, nationality,
  
  

ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health

status or any other aspect of personal status. We are committed to creating a diverse and inclusive

environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you

www.biontech.com