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Associate (m/f) Regulatory Affairs CMC - Germany
Posted on : 12 April 2017
- 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