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