Senior Manager/Associate Director, Global Labelling Oncology (gn)

Our client is a global pharmaceutical company with locations all over the world. This position sits within their newly acquired oncology division.


  • Global European Pharma company
  • International team
  • Strong oncology portfolio

Your advantages:

  • Remote working
  • Attractive salary package with extensive benefits
  • High amount of responsibility and career growth potential


  • Collaborating with the Regulatory Strategy Leads on projects for labelling activities and providing subject-matter expertise on regulatory labelling requirements
  • Independently lead pre- and post-approval labelling activities for assigned products
  • Reviewing proposed labelling to ensure consistency with the CCDS and/or reference labelling.
  • Review of summary documents such as clinical overviews to ensure the labelling message is consistent with the overall representation of a marketing application.
  • Present proposed labelling for global product information documents, including labelling documents in key markets to Senior Management as required for review and approval.
  • Performing quality checks to ensure adherence to EU regulatory requirements and formatting guidelines
  • Management of labelling changes in Quality Management systems as required
  • Working with and managing vendors for translation services (where applicable)
  • Manage core labelling documents (CCDS, SmPCs, PILs etc)
  • Review and approval of labelling artwork in the Artwork Management System
  • Provide labelling support for change control and implementation activities
  • Provide labelling contributions for pharmacovigilance periodic reports
  • Provide strategic advice for the development of labelling activities
  • Lead/contribute to establishment and improvement of working processes and standards as required

Für nähere Informationen kontaktieren Sie bitte: / For more information please contact:

Cristiana Areias
+49 (0) 89 21264542