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RA Manager

Job description

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