Regulatory Affairs Specialist 362

In the frame of a project for one of our Top Clients, we are seeking for a Regulatory Affairs Specialist ( pharmacist ) responsible for ensuring the delivery of regulatory activities performed onsite in Paris region.

About us

Group 10

Under the responsibility of the regulatory coordinator of this project and in close collaboration with subsidiaries, production sites, CMC Regulatory Project Managers, subcontracting platforms involved in this project, supply teams, project managers in charge countries, activities will cover:

  • Coordination of the collection of information relating to regulatory requirements or the analysis of the regulatory impact of changes control
  • Follow-up of the subcontractor in charge of the constitution of variation files according to the legislation and local requirements,
  • Monitoring of the submission of variations / their approval by the local health authorities, in accordance with the established schedule,
  • Monitoring and / or updating of packaging (modification and validation of packaging items)
  • Update, extraction and validation of information from regulatory databases,
  • Establishment and writing of summaries on the progress of the projects
  • Update of dashboards and electronic archiving

Group 11

  • Pharmacist degree is COMPULSORY
  • Degree in Regulatory Affairs is a plus

Group 12

  • Minimum of 5 years ‘experience, in regulatory affairs for pharmaceutical products

Group 13

  • Knowledge and experience with French regulations
  • Knowledge of European Regulations is a plus
  • Master of English and French languages for business continuity
  • Ability to work in a fast paced environment
  • Entrepreneurial mindset
  • Change facilitator
  • Good stress management

Regulatory Affairs Specialist 362