CMC Regulatory Strategy Lead (Hybrid) – Paris/London

Ipsen; Paris; Hybrid; EUR 120,000 - 170,000; Full time

Job summary

Ipsen Innovation (SAS) is seeking a Senior Manager, CMC Regulatory Strategy in a hybrid Paris/London role. You will own CMC regulatory strategy for multiple projects from development to lifecycle management, coordinating with Global Regulatory and external partners to ensure alignment and timely submissions.

The role requires 8–10 years in CMC regulatory activities, strong writing and cross-functional collaboration, plus experience with eCTD formats and health authority interactions.

Qualifications

• Proven direct experience in CMC regulatory environment.
• Experience managing worldwide CMC regulatory activity.
• Strong writing skills for CTD/MAA documents.
• English fluency; French is a plus.

Responsibilities

• Lead development of CMC regulatory strategy roadmaps for projects.
• Collaborate with Pharma Dev/TechOps and SMEs to prepare Dossier sections 1-3.
• Coordinate regulatory submissions (IND/IMPD/MAA) and responses.
• Provide regulatory guidance to project teams and managers.

Skills

CMC Regulatory Strategy

Regulatory Writing

eCTD knowledge

Health Authority Interaction

Global Regulatory Strategy

Project Management

English Fluency

Education

Advanced degree in scientific discipline

Tools

eCTD Publishing

Job description

Ipsen Innovation (SAS) is seeking a Senior Manager, CMC Regulatory Strategy in a hybrid Paris/London role. You will own CMC regulatory strategy for multiple projects from development to lifecycle management, coordinating with Global Regulatory and external partners to ensure alignment and timely submissions.

The role requires 8–10 years in CMC regulatory activities, strong writing and cross-functional collaboration, plus experience with eCTD formats and health authority interactions.