Global CMC Regulatory Strategy Lead

IPSEN; Paris; Presencial; EUR 140.000 - 210.000; Jornada completa

Descripción de la vacante

Ipsen seeks a senior CMC Regulatory Strategy leader to direct the global regulatory strategy for assigned projects from early development through life-cycle management and geographical expansion.

You will coordinate with Global Regulatory Affairs, manufacturing sites, EMOs, and alliance partners to ensure coherent strategies and timely CTD submissions, while mentoring junior staff and steering regulatory intelligence.

Formación

• Proven CMC regulatory experience across small molecules/biologics (3–6 yrs).
• Experience in global regulatory submissions (IND/IMPD/MAA) US/EU and RoW markets.
• Strong technical/regulatory writing and eCTD familiarity.

Responsabilidades

• Lead development of global CMC regulatory strategy and roadmaps for assigned projects.
• Coordinate with Pharmaceutical Development, TechOps and SMEs to deliver compliant CMC dossiers (IND/IMPD, variations, MAA modules 1–3).
• Manage regulatory interactions with sites, CMOs, EMOs, and health authorities.
• Provide regulatory expertise to project teams and mentor junior staff.
• Identify gaps, drive risk-based decisions, and ensure timely submissions and life-cycle management.

Conocimientos

CMC Regulatory Strategy

Regulatory Writing

IND/IMPD/MAA subm.

Project Management

Stakeholder Management

Regulatory Intelligence

Educación

Advanced degree in Pharmaceutical/ Biomedical/ Chemical Science

Herramientas

eCTD publishing

Regulatory databases

Descripción del empleo

Ipsen seeks a senior CMC Regulatory Strategy leader to direct the global regulatory strategy for assigned projects from early development through life-cycle management and geographical expansion.

You will coordinate with Global Regulatory Affairs, manufacturing sites, EMOs, and alliance partners to ensure coherent strategies and timely CTD submissions, while mentoring junior staff and steering regulatory intelligence.