Manager Regulatory Affairs m/f/x Pharma
Berlin Pharma Fulltime
is an internationally active pharmaceutical and chemical group. Based on decades of research activities, our client develops leading pharmaceutical and chemical products that are produced and distributed on a global scale. We are looking for a Manager Regulatory Affairs m/f/x Pharma for the site in Berlin as soon as possible.
- Development and support of regulatory projects through the entire life cycle, both in the context of quality management and in operational implementation
- Coordination of working groups for the optimization of processes in the area of drug approval as well as support of the working groups
- Application for clinical studies as well as submission of corresponding documentation to internal and external cooperation partners
- Compilation of registration dossiers including monitoring of procedures as well as processing of deficiency reports, change notifications and extensions
- Analysis of specific regulatory requirements including the development of the regulatory strategy under observation of current guidelines and precedents
- You have a successfully completed university degree in biology, pharmacy or another discipline in the field of life science
- Sound professional experience in regulatory or medical affairs and/or in the management of clinical studies, preferably in an international pharmaceutical environment
- Knowledge of regulations of local health authorities (FDA / EMA) as well as in the field of drug development
- Routine handling of the common MS Office products as well as very good English skills
- Personally, you are characterized by communication and team skills as well as a confident appearance
If you find yourself in this challenging position, we look forward to receiving your complete application documents, stating your income expectations and your earliest possible availability.