Senior Regulatory Affairs Lead — Lifecycle & Submissions

IQVIA; Courbevoie; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

IQVIA in France seeks a Senior Regulatory Affairs Specialist to lead country-level regulatory activities for medicinal products, ensuring compliance and lifecycle management across portfolios. You will collaborate with Medical Affairs, Quality, Commercial and Global Regulatory teams, prepare submissions, review labeling and artwork, and stay ahead of regulatory changes to support timely approvals.

This fixed-term 12-month contract offers the opportunity to contribute to strategic regulatory

Qualifications

• Bachelor's degree in Pharmacy or Life Sciences required.
• Significant regulatory affairs experience in pharma.
• Knowledge of French regulatory requirements and submissions.
• Experience with lifecycle management activities.
• Fluent French and English communication.

Responsabilités

• Lead country-level regulatory activities for medicinal products in France.
• Prepare and submit variations, renewals, and MAH transfers.
• Review promotional materials for compliance with regulations.
• Coordinate with Medical Affairs, Quality, and Global Regulatory teams.
• Monitor regulatory changes and advise on business impact.

Connaissances

Regulatory Affairs

Lifecycle Management

Regulatory submissions

Cross-functional collaboration

Formation

Bachelor's degree in Pharmacy/Life Sciences

Outils

Regulatory IT systems

Artwork review tools

Description du poste

IQVIA in France seeks a Senior Regulatory Affairs Specialist to lead country-level regulatory activities for medicinal products, ensuring compliance and lifecycle management across portfolios. You will collaborate with Medical Affairs, Quality, Commercial and Global Regulatory teams, prepare submissions, review labeling and artwork, and stay ahead of regulatory changes to support timely approvals.

This fixed-term 12-month contract offers the opportunity to contribute to strategic regulatory