CMC Regulatory Strategy Manager - Global Submissions

Ipsen Biopharmaceuticals Inc.; Paris; On-site; EUR 120,000 - 160,000; Full time

Job summary

Ipsen Innovation (SAS) in Paris is seeking a Manager CMC Regulatory Strategy to lead CMC regulatory strategy development for projects from early clinical trials through initial marketing applications and lifecycle management. You will drive the preparation of CMC submissions and ensure alignment with regulatory requirements across regions.

Collaborating with Global Regulatory Affairs, Pharmaceutical Development, and external partners, you will identify gaps, coordinate dossiers, and advise on

Responsibilities

• Lead the development of CMC regulatory strategy roadmaps for assigned projects, including lifecycle management and geographic expansion.
• Coordinate the CMC regulatory section of submissions (IND/MAA/CTD modules) with cross-functional teams.
• Prepare regulatory documents and update CTD sections with process and analytical data.
• Collaborate with Global Regulatory Affairs and SMEs to ensure alignment of CMC strategy with overall regulatory strategy.
• Identify and address CMC regulatory gaps for planned submissions and country-specific requirements.
• Interact with site regulatory authorities, alliance partners, and CMOs on regulatory aspects and submissions.

Job description

Ipsen Innovation (SAS) in Paris is seeking a Manager CMC Regulatory Strategy to lead CMC regulatory strategy development for projects from early clinical trials through initial marketing applications and lifecycle management. You will drive the preparation of CMC submissions and ensure alignment with regulatory requirements across regions.

Collaborating with Global Regulatory Affairs, Pharmaceutical Development, and external partners, you will identify gaps, coordinate dossiers, and advise on