Senior CMC Regulatory Strategy Lead

Ipsen Biopharmaceuticals Inc.; Paris; On-site; EUR 100,000 - 140,000; Full time

Job summary

Ipsen Innovation (SAS) seeks a Senior Manager, CMC Regulatory Strategy to oversee CMC regulatory strategy across development to market. You will coordinate with R&D, TechOps, and external partners to ensure alignment of regulatory plans and timely submission of dossiers.

The role focuses on leading CMC regulatory interactions, developing lifecycle strategies, and guiding junior staff in regulatory affairs across global markets.

Qualifications

• Experience leading CMC regulatory strategy for development projects.
• Ability to assemble and oversee CMC regulatory dossiers from development through lifecycle.
• Strong collaboration with R&D, TechOps, and external manufacturing partners.

Responsibilities

• Lead development of CMC regulatory strategy roadmaps for assigned projects.
• Prepare the CMC portion of regulatory dossiers in collaboration with PD/TechOps teams.
• Coordinate with Global Regulatory Affairs leads to integrate CMC strategy into overall regulatory plans.
• Define and execute CMC regulatory plans for R&D and lifecycle management.
• Incorporate regional regulatory needs and emerging requirements into global plans.
• Manage regulatory interactions for site registrations, licences, and filings.

Skills

CMC Regulatory Strategy

Regulatory Planning

Cross-functional collaboration

Dossier preparation

Job description

Ipsen Innovation (SAS) seeks a Senior Manager, CMC Regulatory Strategy to oversee CMC regulatory strategy across development to market. You will coordinate with R&D, TechOps, and external partners to ensure alignment of regulatory plans and timely submission of dossiers.

The role focuses on leading CMC regulatory interactions, developing lifecycle strategies, and guiding junior staff in regulatory affairs across global markets.