Regulatory Affairs Manager/-in (m/f/d)

Coordination and management of national and European procedures for market authorisation and its follow-up procedures Pre-examination of procedures and assessment of formal-regulatory conditions and legal basis This includes documentation, validation, time-limit monitoring and the preparation of expert opinions Consultation of drug users on process-related and regulatory issues Exchange with EU authorities and pharmaceutical companies Representation of regulatory positions in internal and external bodies or Work for the committee representatives

Completed academic studies (master or comparable) of natural sciences (e.g. biology, chemistry, pharmacy, medicine) A promotion is desirable Professional experience and knowledge in the field of immunology and protein biochemistry, e.g. in the pharmaceutical industry knowledge in the field of drug regulation, e.g. to assess the quality of immunoglobulins and/or antibody-containing products, appropriate professional experience desirable Embossed organizational and coordination skills Ability to analytical thinking and interdisciplinary cooperation readiness and ability to work quickly and independently on new topics High flexibility and durability Very good knowledge of German and English in word and writing Secure handling of Microsoft Office, databases and modern data communication Please note that a Declaration of Interests vis-à-vis the EMA as well as a statement in accordance with § 77a AMG must be submitted in the event of the conclusion of the contract.

is a versatile and demanding workplace 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 payment of the year, pension of the company and benefits in terms of assets. The employment relationship is limited to three years. Parttime employment is generally possible. The post is rated according to E 13 TVöD, part I of Appendix 1 of the TVEntgO Bund. The assignment to the stages takes place taking into account the personal relevant experiences. Disabled applicants (m/w/d) are preferably taken into account with the same suitability. The Paul-Ehrlich-Institut promotes equality between people and the reconciliation of family and work. For this we offer, among other things, very flexible working hours (part-time models, no core working hours), hybrid work (max. 60% remote), kindergarten places and numerous training opportunities. Our company health management and the promotion of the job ticket complete the offer. .