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RA Manager
- Posted 14 December 2022
- LocationBaden-Württemberg
- Job type Permanent
- Reference75532
- Contact NameDavid Skinner
Job description
Regulatory Affairs Manager
Your tasks:
Your profile:
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