Group 10
Responsabilities

In the context of a project for one of our top Pharma client, we’re looking for a talented Regulatory Affairs Officer to lead the following missions, and much more!

  • Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements (France)
  • Provide on-going regulatory advice to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives
  • Provide regulatory support to clients and associate companies
  • Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling
  • Review tasks for, support and mentor Regulatory Affairs Associates

Group 13
Profile

  • Degree in Life Science/ Pharmacy degree would be a plus
  • Experience in Regulatory Affairs on Module I for European Union (experience for France would be a plus)
  • Knowledge of EU regulations for pharmaceuticals
  • Excellent communication skills in French (written fluency a must, verbal fluency preferred), good level of English
  • Excellent attention to details
  • Ability to work well within a multicultural team
  • Good time management skills

Regulatory Affairs Officer 412