Regulatory and professional accompaniment of the consortium in matters of production, quality control and non-clinical studies for the development of future iN-KEY drugs for novel therapies (ATMP) Ensuring compliance with regulatory requirements and clinical translation requirements Assessment of the quality and production data of ATMP in the framework of applications for market authorisation and approval applications for clinical trials at national and European level early and continuous interaction with the relevant national and European regulatory authorities Integration of regulatory research related to the EU project iN-KEY Technical assistance in the preparation of all quality-related and non-clinical documentation required to carry out a first-in-human clinical trial Cooperation in the development of regulatory guidelines in the field of products based on pluripotent stem cells Representation of the Paul-Ehrlich Institute in national and international bodies

Completed academic studies (master or comparable) of life sciences or natural sciences (e.g. molecular biology or biochemistry) Completed doctorate Interest and knowledge in molecular and cell biology and gene and cell therapy Knowledge and experience in immunological and protein biochemical data analysis Knowledge of human iPSC and/or embryonic stem cells is advantageous Knowledge and/or experience in drug regulation are advantageous Safe handling of Microsoft Office and modern data communication Ability to analytical thinking and interdisciplinary cooperation High flexibility and durability Very good knowledge of English and German in word and writing Please note that a Declaration of Interests vis-à-vis the EMA as well as a statement pursuant to § 77a para. 1 p. 2 AMG must be delivered.

is a versatile and demanding workstation centrally located in the Rhine-Main area with good connections to the public transport network (car, airport, S-Bahn). As an employer of the public service, we offer the usual social benefits, such as special payments for the year, pensions and benefits. The employment ratio is limited to three years and six months and to 50% in parttime (corresponding to 19.5 hours per week). The post is rated according to E 14 TVöD, part I of Appendix 1 of the TVEntgO Bund. The assignment to the stages takes place taking into account the personal relevant experience. Disabled applicants (m/w/d) are preferably taken into account with the same suitability. The Paul-Ehrlich-Institut promotes the equality of people and the reconciliation of family and work. For this purpose, we offer, inter alia, very flexible working times (part-time models, no core working times), hybrid work (max. 60% remote), kindergartens and numerous training opportunities. Our occupational health management and the promotion of the job ticket complete the offer. .