Senior Manager, CMC Regulatory Strategy (Hybrid)

Ipsen Innovation (SAS); Paris; Hybrid; EUR 90,000 - 160,000; Full time

Job summary

Ipsen Innovation (SAS) is seeking a Senior Manager, CMC Regulatory Strategy to lead regulatory strategy for CMC across development stages and geographies. You will manage interactions with regulators, coordinate submissions and drive alignment with Global Regulatory Affairs and manufacturing partners.

The role requires an advanced degree and senior experience in CMC, strong writing and project leadership, and the ability to coach junior colleagues while delivering timely dossiers Ready For

Qualifications

• Proven experience in CMC regulatory processes for US, EU and export markets.
• Ability to lead regulatory submissions and liaise with authorities.
• Strong writing, analytical and organizational skills.
• Experience with global/regional project teams.

Responsibilities

• Lead the CMC regulatory strategy for assigned projects across development phases and geographies.
• Coordinate the preparation of CMC sections for IND/MAA/CTA submissions.
• Collaborate with Pharmaceutical Development, TechOps, and SMEs to ensure submission readiness.
• Manage regulatory interactions with global authorities and external partners.
• Develop and maintain CMC trackers, KPIs and submission timelines.
• Coach and develop junior regulatory staff within the CMC group.

Skills

CMC Regulatory Strategy

Regulatory Writing

Cross-functional collaboration

Project management

Education

Advanced degree in scientific discipline

Job description

Ipsen Innovation (SAS) is seeking a Senior Manager, CMC Regulatory Strategy to lead regulatory strategy for CMC across development stages and geographies. You will manage interactions with regulators, coordinate submissions and drive alignment with Global Regulatory Affairs and manufacturing partners.

The role requires an advanced degree and senior experience in CMC, strong writing and project leadership, and the ability to coach junior colleagues while delivering timely dossiers Ready For