CMC Regulatory Strategy Lead - Global Biopharma

Ipsen Innovation (SAS); Paris; Hybride; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Ipsen Innovation (SAS) is seeking a Manager CMC Regulatory Strategy to lead global CMC regulatory planning for development and lifecycle management. You will manage dossiers, coordinate with sites and external partners, and ensure alignment with regulatory requirements across markets.

The role requires strong regulatory writing, strategic thinking and experience in IND/IMPD and MAA modules, with a focus on minimizing risk and accelerating patient access.

Qualifications

• Proven CMC regulatory experience in global development and submissions.
• Experience across IND/IMPD, MAA modules, and post-approval activities.
• Strong technical writing and cross-functional collaboration skills.

Responsabilités

• Lead development of CMC regulatory strategy roadmaps for projects.
• Coordinate preparation of CMC dossier sections and CTD updates.
• Collaborate with Global Regulatory, SMEs and sites to align strategy.
• Identify and address regulatory gaps; manage lifecycle submissions.

Connaissances

CMC Regulatory

Regulatory Writing

Global Submissions

Project Leadership

Formation

Advanced degree in scientific discipline

Outils

eCTD software

Regulatory databases

Description du poste

Ipsen Innovation (SAS) is seeking a Manager CMC Regulatory Strategy to lead global CMC regulatory planning for development and lifecycle management. You will manage dossiers, coordinate with sites and external partners, and ensure alignment with regulatory requirements across markets.

The role requires strong regulatory writing, strategic thinking and experience in IND/IMPD and MAA modules, with a focus on minimizing risk and accelerating patient access.