Global CMC Regulatory Strategy Lead

Ipsen; Paris; Hybrid; EUR 90,000 - 150,000; Full time

Job summary

Ipsen Innovation (SAS) in Paris is seeking a Manager CMC Regulatory Strategy to lead global CMC regulatory efforts across development stages. You will partner with manufacturing, external partners and regulatory teams to shape strategies and ensure readiness for submissions.

The role requires 3–6 years of CMC experience, strong writing and stakeholder management, and an advanced scientific degree. Hybrid collaboration and international coordination are expected.

Qualifications

• Proven CMC Regulatory experience with global submissions (IND/ IMPD / MAA) across major markets.
• Leadership in developing global CMC regulatory strategies for multiple projects.
• Strong technical writing, data interpretation, and regulatory intelligence skills.

Responsibilities

• Lead development of CMC regulatory strategy roadmaps for assigned projects.
• Prepare CMC sections of dossiers and briefing documents for regulatory positions.
• Collaborate with Pharmac Dev, TechOps and GRA to ensure submission readiness.
• Coach junior staff and manage project timelines and communications.

Skills

CMC Regulatory Strategy

Regulatory Writing

Project Management

Stakeholder Management

Team Leadership

Education

Advanced degree in scientific discipline

Tools

eCTD familiarity

Job description

Ipsen Innovation (SAS) in Paris is seeking a Manager CMC Regulatory Strategy to lead global CMC regulatory efforts across development stages. You will partner with manufacturing, external partners and regulatory teams to shape strategies and ensure readiness for submissions.

The role requires 3–6 years of CMC experience, strong writing and stakeholder management, and an advanced scientific degree. Hybrid collaboration and international coordination are expected.