CMC Regulatory Strategy Lead for Global Programs

Ipsen Pharma SAS; Paris; On-site; EUR 130,000 - 165,000; Full time

Job summary

Ipsen Innovation (SAS) is seeking a Senior Manager, CMC Regulatory Strategy to drive the CMC regulatory roadmap for multiple development projects. You will lead regulatory interactions with global teams and external partners, ensuring submissions meet eCTD standards and alignment with Ipsen's overall regulatory strategy.

You will mentor junior colleagues, coordinate with Pharma Development/TechOps, and shape strategies for lifecycle management and geographic expansion across markets.

Qualifications

• Experience leading CMC regulatory strategy for development projects.
• Ability to coordinate with R&D, TechOps, and external partners.
• Proven experience in preparing and defending CMC modules for submissions.

Responsibilities

• Lead the development of the CMC regulatory strategy and roadmaps for assigned projects.
• Coordinate and prepare the CMC portion of regulatory dossiers (IND/IMPD, MAA) to Ready For Submission standards.
• Manage CMC regulatory interactions with GRA, EMO SMEs, CMOs and Alliance partners.
• Coach and develop junior CMC-reg colleagues and ensure timely submissions.
• Ensure alignment of CMC regulatory plans with overall regulatory strategy across projects.

Skills

CMC Regulatory Strategy

Regulatory Leadership

Dossier Preparation

Stakeholder Collaboration

Regulatory Submissions

Regulatory Intelligence

Job description

Ipsen Innovation (SAS) is seeking a Senior Manager, CMC Regulatory Strategy to drive the CMC regulatory roadmap for multiple development projects. You will lead regulatory interactions with global teams and external partners, ensuring submissions meet eCTD standards and alignment with Ipsen's overall regulatory strategy.

You will mentor junior colleagues, coordinate with Pharma Development/TechOps, and shape strategies for lifecycle management and geographic expansion across markets.