NOVRJP00001564 ANÜ Labeling

Location: München, Bayern Salary: Verhandelbar
Sector: Life Sciences Type: Temporary


  • Update core texts SmPCs/PL/Labelling for EU registration procedures MRP/DCP/CP in English for variations and renewals. Coordinate translations for CPs.
  • Define submission strategy for EU and interact with HA as needed.
  • Ensure in-time hand-over of variation package or response documents to submission teams.
  • Interact with country organizations, medical departments and pharmacovigilance to ensure timely submission of labelling changes.
  • Maintain databases and sharepoints as defined.
  • Coordinate labelling projects or specific safety tasks as assigned.
  • Review and comment on internal or external guidelines and regulations on regulatory, safety and legal topics.
  • Represent Global Labelling team in inspections and audits.
  • Technical and administrative support to Senior Global Labelling Managers and Head of Global Labelling.
  • Mentor less experienced team members.


  • erste Erfahrung in der Zulassung
  • Erfahrung Labeling
  • erfolgreiches Studium naturwissenschaftlicher Bereich
  • Deutsch / Englisch:

  • Start: ASAP
  • Laufzeit: 11 Monate
  • Art der Anstellung: Arbeitnehmerüberlassung