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Associate (m/f) Regulatory Affairs CMC Mainz Germany,  


Posted on : 12 April 2017

Project Description

Everyone achieves greatness at BioNTech! 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 Have we kindled your pioneering spirit? Then apply now for our location Mainz and look forward to becoming part of a highly qualified, motivated, and collegial team, in which you ll quickly take on your own responsibilities. Simply send us your application documents using our our online form. If you have any further questions, Christina Kurz will be happy to answer them on +49 (0) 6131-9084-1291 (monday-friday, 1 p.m. - 6 p.m.).    

Locations

Mainz

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