Group 10

In the context of team expansion, we are looking for a new experienced Regulatory figure to join our dynamic international teams for the following missions :

  • Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements for the Nordic Countries
  • Gain regulatory authority approval and liaise with the authorities
  • 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
  • Liaise with external regulatory authorities as required
  • 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 Officers and Associates

Group 13

  • Scientific studies, pharmacist would be a plus,
  • Mastering of at least one  Nordic language, and English
  • Proven experience in regulatory affairs in the Nordics (around 5 years)
  • Entrepreneurial and independent working style
  • Knowledge of specific IT systems (ERP, Productlifecycle management…) RIMS: Veeva Vault Registrations, Register/LifeSphere, Liquent Insight, Ennov RIM is appreciated

Senior Regulatory Affairs Specialist 172