You will join the Regulatory Affairs Department and work on a range of products, participating in various regulatory activities throughout the drug lifecycle
Job Summary
You will join the Regulatory Affairs Department and work on a range of products, participating in various regulatory activities throughout the drug lifecycle.
Key responsibilities include contributing to the preparation and submission of AMM variation dossiers, monitoring ongoing evaluations by authorities, and managing packaging changes.
This role offers the opportunity to be involved in regulatory coordination for new RCP and leaflet updates, as well as participating in team meetings and transversal projects.
Matching Summary
You will join the Regulatory Affairs Department and work on a range of products, participating in various regulatory activities throughout the drug lifecycle.
Skills & Requirements
Must-have
Regulatory Affairs France and Europe
Drug lifecycle regulatory activities
Submission of AMM variation dossiers
Follow-up of dossiers with authorities
Management of packaging changes
Professional English proficiency
Nice-to-have
Open and curious mindset
Results and internal client oriented
Adherence to processes
Key Requirements
Student in Pharmacy or scientific Master 2
Focus on Regulatory Affairs / Registration
Knowledge of health authorities structure
Familiarity with pharmaceutical laboratory organization
Proficiency with Outlook, Teams, Word, Excel, PowerPoint, Internet, and databases