München: Regulatory Affairs & Quality Manager (gn) | Pharma
Our client is a research-based, independent and family owned medium-sized pharmaceutical company with a successful product portfolio and promising pipeline in various highly profitable indication areas.
In Munich we are searching for a:
REGULATORY AFFAIRS & QUALITY MANAGER (all genders)
- Write, update and submit regulatory affairs documents (incl. CMC)
- Support regulatory strategy and communication
- Communicate with national and European regulatory authorities (PEI, BfArM, AGES, European Medicines Agency (EMA), etc).
- Labelling: Coordination of all activities for the periodic updating of the product information texts (Package Leaflet, SmPC, Labeling, etc)
- Maintenance of the Quality Management System: preparation and modification of SOP‘s
- Support regarding the preparation, performance, and finalization of inspections (Audits).
- Coordination of pharmaceutical complaints
- profound experience in the field of Regulatory Affairs
- experience in the field of Quality Assurance is a nice to have (but not a must)
- university´s degree in pharmaceutics or other natural sciences (e.g. Biology, Chemistry)
- fluent communication skills in German and excellent communication skills English
- A great team spirit
- Excellent working conditions in a new office
- flexible working hours including partial homeoffice
- Extensive training
- Great salary package (and other benefits)
- Opportunities for personal and professional growth
Do you want to know more about this position?
Then please send your complete application to:
Silvio Di Meglio or Mariana Chaumont
Triga Consulting GmbH & Co. KG
TRIGA – Wir vermitteln nicht nur Personal, sondern Menschen. Engagiert, erfahren und erfolgreich.