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Associate (m/f) Regulatory Affairs CMC - Germany  

Biontech (company)


Posted on : 12 April 2017

Project Description

  • Everyone achieves greatness at our company!
  •  As one of the most rapidly growing biotechnology companies in Europe, we’re working on revolutionary approaches in the fight against cancer and other diseases. 
  • Over 500 dedicated, passionate pioneers achieve sensational success and promising breakthroughs time and again by forging new paths – and ensure people all around the world have hope for the future. You too can become a pioneer! 
  •  Here, you’ll achieve greatness. As a member of our team, you will soon be a participant in the next crucial step we take. 
  • It will be your responsibility to review the regulatory requirements for our clinical trials of individualized cancer therapies and to ensure that they are complied with. 

Your duties in detail:  
  • In this connection you will be creating the CMC documentation for inclusion in approval dossiers for clinical test products. 
  • In addition, you will handle dossier compliance management and review GMP documentation. 
  • Naturally, you will also be responsible for documenting and evaluating planned and unplanned discrepancies in the production and quality control of RNA-based immunotherapeutics. 
  • In addition, you will support the development of regulatory strategies for personalized immunotherapies  
  • Last but not least, you will coordinate new regulatory concepts with the authorities (such as in connection with scientific advice).   

What you have to offer.  
  • Completed course of studies in the natural sciences - ideally with a doctorate - in chemistry, pharmacy, biochemistry, biology or comparable discipline 
  • Experience in working with RNA, preferably in a GMP environment 
  • Experience writing the documents required for approval of clinical trials (IMPD, PSF) 
  • Distinct organizational talent, a structured and solution-oriented approach to work, as well as analytical and conceptual skills