Regulatory Affairs Manager
On-siteCourbevoie, Île-de-France, France
Courbevoie, Île-de-France, FranceOn-siteFull TimeSenior LevelBachelors DegreeSmall
Full TimeSenior LevelBachelors DegreeSmall
Job Summary
Manage country-level regulatory activities for medicinal products in France, ensuring full compliance with local requirements. Prepare and coordinate regulatory submissions, including notifications, renewals, variations, and MAH transfers, while leading processes with local Health Authorities. Prepare and translate product labelling into French, review artwork, and monitor pharmaceutical legislation updates. This fixed-term role supports successful product lifecycle management for global pharmaceutical clients within IQVIA's global team dedicated to advancing healthcare.
Required Qualifications
- Bachelor of Pharmacy or other Life Sciences degree
- 3+ years of experience in regulatory affairs for medicinal products on French market, including submission document preparation and coordination
- Excellent knowledge of pharmaceutical legislation and regulatory requirements in France
- Native French and fluent written and verbal communication skills in English
- Must be able to work in a fixed-term opportunity for 12 months
Desired Qualifications
- Experience within a large regulatory organization, with both centralized and local activities
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