Nymphenburger Str.120, 80636 München+49 (0)89 80913072-0info@triga-consulting.de
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Nymphenburger Str.120, 80636 München+49 (0)89 80913072-0info@triga-consulting.de

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)

Tasks:

  • 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

Requirements:

  • 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

We offer:

  • 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
Tel.: 0049-(0)89-80913072-1
dimeglio@triga-consulting.de
www.triga-consulting.de

 

 

 

 

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