Regulatory Affairs Manager

Responsibilities

• Manage country-level regulatory activities for medicinal products to ensure full compliance with local requirements
• Prepare and coordinate regulatory submissions, including notifications, renewals, variations, new applications, and MAH transfers
• Lead submission processes with local Health Authorities and manage follow-ups through approval
• Prepare and translate product labelling into French, such as SmPC and PIL
• Review and approve artwork and promotional materials within client systems
• Support regulatory maintenance activities across multiple pharmaceutical products
• Monitor local pharmaceutical legislation and ensure all updates are applied appropriately

Requirements

• Bachelor of Pharmacy or Life Sciences degree
• 3+ years of regulatory affairs experience for medicinal products on the French market
• Excellent knowledge of French pharmaceutical legislation and regulatory requirements
• Native French language skills
• Fluent written and verbal communication skills in English
• Strong organizational skills and attention to detail
• Proficiency in MS Office; experience with regulatory information systems or artwork tools is a plus

Preferred Qualifications

• Experience working within a large regulatory organization involving both centralized and local activities

About the Company

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.