Group 10
RESPONSIBILITIES

As responsible for the Labeling activities you:

  • Manage labeling processes and its potential improvements
  • Organize the activities of the Global Labeling Committee (GLC)
  • Follow up on CCDS creation / maintenance plans and other product information in relation to project teams
  • Establish the schedule for updating the labeling and report its progress to the GLC
  • Disseminate product information and supervise their implementations at the local level
  • Helping Clinical and Regulatory Product Leaders by monitoring competitive labeling for the development of TPPs, CCDS and Product Information
  • Are responsible for the regulatory compliance of the labeling documents intended for the Competent Authorities
  • Inform about regulatory labeling requirements and provide any support information
  • Develop regional instructions for use of combined drugs / medical devices when applicable
  • Act as an expert during labeling negotiations with the authorities when necessary
  • Communicate newly approved labels internally

Group 10
SKILLS

  • Excellent communication (written and verbal) in French and English
  • Experience on regulatory labeling aspects
  • Rigorous, structured and organized
  • Action oriented
  • Ability to solve problems
  • Know how to manage priorities
  • Robust transversal management
  • International work experience
  • Professional experience of at least 5 years on labeling aspects

TRAINING

  • Preferably scientific training
  • Knowledge of Quality Assurance aspects a plus

Labelling Manager 417