Senior Regulatory Affairs Leader – Global Lifecycle Expert

iqvia; Paris; On-site; EUR 60,000 - 85,000; Full time

Job summary

IQVIA is seeking a Senior Regulatory Affairs Specialist to lead country-level regulatory activities for medicinal products in France. You will prepare submissions, manage lifecycle activities, and maintain compliant regulatory records across a diverse portfolio.

You will collaborate with Medical Affairs, Quality, Commercial and Global Regulatory teams to drive approvals and ensure high-quality outcomes for patients and healthcare systems. French and English fluency required.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, or related field.
• Significant regulatory affairs experience in pharma, including post-approval activities.
• Knowledge of local regulatory requirements and submission procedures.
• Experience lifecycle management: variations, renewals, labeling updates, MAH transfers.
• Experience reviewing promotional materials for France per codes.
• Strong multitasking, attention to detail, and stakeholder management.
• Fluent in French and English; able to work with global teams.

Responsibilities

• Lead country-level regulatory activities for medicinal products in France.
• Prepare, coordinate, and submit regulatory documentation for lifecycle activities.
• Act as regulatory contact for clients and Health Authorities; drive submissions to approval.
• Support end-to-end lifecycle management and maintain compliant regulatory records.
• Review and approve promotional/non-promotional materials in France.
• Review artwork, labeling updates, and packaging components for consistency.
• Monitor changes in local regulation and advise on actions.
• Collaborate with Medical Affairs, Quality, Commercial, and Global Regulatory teams.
• Contribute to process improvements and share regulatory knowledge.

Skills

Stakeholder management

Communication skills

Problem-solving

French language

English language

MS Office

Regulatory systems

Education

Bachelor's degree in Pharmacy or Life Sciences

Tools

Artwork review tools

Regulatory information management systems

Job description

IQVIA is seeking a Senior Regulatory Affairs Specialist to lead country-level regulatory activities for medicinal products in France. You will prepare submissions, manage lifecycle activities, and maintain compliant regulatory records across a diverse portfolio.

You will collaborate with Medical Affairs, Quality, Commercial and Global Regulatory teams to drive approvals and ensure high-quality outcomes for patients and healthcare systems. French and English fluency required.