CMC manager (Small Molecules) – France

Why Join Us?  

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.  

Here’s what makes us unique

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.  

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission. About the Job  

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.  

This role is an exciting opportunity to lead and deliver the post-approval activities across all global markets for commercial small molecule products.

 Main Responsibilities 

• Lead the CMC Regulatory strategy for all post-approval activities of the asset, providing proactive and timely advice to the technical team.
• Manage and deliver all regulatory aspects related to Change Control requests
• Lead and deliver all project management activities to support the CMC post-approval work of the asset to ensure the necessary regulatory documents are delivered in time and with the adequate quality.
• Liaise with the Local Affiliates as needed to develop efficient regulatory strategies to deliver the CMC Dossier in line with country requirements and agreed timelines
• Represent CMC Regulatory across the relevant governance meetings and activities
• Write, review and compile (as needed) all regulatory documents in support of each submission on time and in line with country requirements
• Generate gap analysis and risk management support for each submission as needed
• Identify rate limiting deliverables and interdependencies across the technical and regulatory aspects of the different submissions
• Provide status updates to all stakeholders as needed
• Management of all documents through the document management system