Senior Manager, CMC Regulatory Strategy (Hybrid)

Ipsen; Paris; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

Ipsen Innovation (SAS) is seeking a Manager CMC Regulatory Strategy to drive CMC regulatory strategy across development to lifecycle management. You will coordinate with manufacturing sites, EMOs, and global teams to ensure timely, compliant submissions and an optimized regulatory pathway.

The role emphasizes leading complex dossiers (IND/IMPD, MAA modules) and shaping global strategies, with emphasis on risk management and cross-functional leadership in a hybrid Paris-based setup.

Qualifications

• Proven CMC Regulatory experience in managing small molecules and/or biologicals (3–6 years).
• Experience in US, EU and RoW regulatory submissions.
• Advanced degree in scientific discipline.
• Fluent in English.

Responsibilities

• Lead development of the CMC regulatory strategy (roadmaps) for multiple projects ensuring coherence across programs.
• Lead preparation of the CMC dossier with development and operations teams to meet timelines.
• Write regulatory technical documentation including CTD sections with data from reports and batch records.
• Coordinate with Global Regulatory Affairs to align CMC strategy with overall regulatory goals.
• Anticipate gaps for submissions and plan strategies addressing country-specific requirements.
• Communicate with global regulatory lead to de-risk CMC decisions.
• Lead compilation of briefing documents for regulatory positioning.
• Provide CMC regulatory expertise to project teams.
• Propose innovative CMC pathways to accelerate product delivery.
• Review Target Product Profile, risk assessments, and regulatory documents for alignment.

Skills

CMC Regulatory Strategy

Regulatory Writing

Cross-functional leadership

Project management

Regulatory submission planning

Regulatory intelligence

Communication with authorities

Global regulatory affairs

Education

Advanced degree in Pharmaceutical/Medical/Biological/Chemical Sciences

Tools

eCTD publishing software

Regulatory information systems

Job description

Ipsen Innovation (SAS) is seeking a Manager CMC Regulatory Strategy to drive CMC regulatory strategy across development to lifecycle management. You will coordinate with manufacturing sites, EMOs, and global teams to ensure timely, compliant submissions and an optimized regulatory pathway.

The role emphasizes leading complex dossiers (IND/IMPD, MAA modules) and shaping global strategies, with emphasis on risk management and cross-functional leadership in a hybrid Paris-based setup.