Director CMC Regulatory Affairs (M/F)

Long Description

This is very unique an exciting opportunity to work delivering the Regulatory CMC strategy for a rapidly growing development pipeline that includes both standard organic molecules and chemically synthetised oligonucleotides. Servier is undergoing a very significant transformation, and as part of this role you will have the opportunity to shape the future of the Regulatory CMC department and the wider Company beyond project work.

Key Responsibilities:

• Lead the global Regulatory CMC strategy for multiple development assets.
• Define and execute strategies to maximize regulatory outcomes and accelerate product delivery to patients.
• Deliver high-quality, timely delivery of regulatory documents.
• Represent CMC Regulatory in cross-functional meetings and agency interactions.
• Serve as a Subject Matter Expert on key regulatory topics.
• Lead transversal projects as part of the ongoing transformation of the Regulatory CMC function

Profile:

• 15+ years in CMC regulatory processes and drug development.
• Proven track record leading Marketing Authorisation submissions globally, especially in late-phase development.Strong strategic regulatory skills and knowledge of ICH, FDA, and EMA guidelines.
• Excellent analytical, critical thinking, and problem-solving abilities.
• Collaborative team player with strong communication skills.

We welcome candidates with diverse backgrounds and career aspirations, including those without prior management experience. If you’re ready to make an impact in a truly promising development pipeline, we want to hear from you!

Apply now and be part of our growth journey!

Director CMC Regulatory Affairs MF • GIF-SUR-YVETTE, FR,