Senior CMC Regulatory Strategy Lead

Ipsen; Paris; On-site; EUR 110,000 - 150,000; Full time

Job summary

Ipsen is seeking an experienced CMC Regulatory Director to lead the regulatory strategy for assigned projects from development through lifecycle management. You will coordinate with Global Regulatory Affairs, Manufacturing, and external partners to ensure compliant CMC submissions and timely interactions with authorities.

Ideal candidates will have 8–10 years in CMC regulatory roles, strong writing skills, and the ability to navigate complex global regulatory landscapes.

Qualifications

• Proven direct experience in CMC regulatory environment in pharmaceutical industry (8–10 years).
• Experience managing CMC-regulatory activity for products worldwide.
• Experience with regulatory writing, eCTD formats and publishing support functions.
• Fluent English; French is preferred.

Responsibilities

• Lead the development of CMC regulatory strategy and roadmaps for R&D and lifecycle management.
• Coordinate with Pharmaceutical Development, TechOps, and SMEs to prepare CMC dossiers (IND, IMPD, MAA).
• Manage regulatory interactions with Health Authorities and external partners.
• Provide regulatory expertise to project teams and mentor junior staff.

Skills

CMC regulatory strategy

Regulatory leadership

Cross-functional collaboration

Analytical thinking

Communication skills

Education

Advanced degree in Pharmaceutical/Medical/Biological/Chemical Science

Job description

Ipsen is seeking an experienced CMC Regulatory Director to lead the regulatory strategy for assigned projects from development through lifecycle management. You will coordinate with Global Regulatory Affairs, Manufacturing, and external partners to ensure compliant CMC submissions and timely interactions with authorities.

Ideal candidates will have 8–10 years in CMC regulatory roles, strong writing skills, and the ability to navigate complex global regulatory landscapes.