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Regulatory Affairs Manager

Your tasks:

Creation and processing of pre-clinical approval documents as well as processing of official notifications of defects
Creation and updating of toxicological assessments for our ingredients and medicinal products
Support in creating, checking and adapting packaging texts according to the content of the pre-clinical approval documents
Follow-up, assessment and, if necessary, implementation of new official requirements for toxicological assessment and other requirements for pre-clinical approval documentation in close cooperation with other affected areas
Communication and correspondence with local partners regarding toxicological and regulatory issues as well as holding discussions with the responsible authorities

Your profile:

Completed scientific studies, ideally in toxicology
Professional experience desirable, ideally in the registration and approval of medicinal products
Begun or successfully completed further training as a specialist toxicologist (registered European toxicologist ERT) is desirable
Knowledge of risk assessment and experience in using in silico/QSAR methods are helpful
Knowledge of the guidelines relevant to approval
Confident in dealing with MS Office products
Very good knowledge of English, another foreign language would be an advantage
Goal orientation, ability to work in a team and a high degree of independence, diligence and adherence to deadlines