CMC Leader

At Excelya, we are committed to fostering an environment defined by Audacity, Care, and Energy. As a Clinical Operations Lead , you will play a vital role in enhancing our clinical research strategies and ensuring operational excellence across our studies.

This position offers a unique opportunity to lead strategic CMC regulatory initiatives while collaborating with cross-functional stakeholders to ensure the highest standards of quality and compliance. You will play a key role in driving regulatory excellence, supporting complex global submissions, and contributing to innovative development and lifecycle management strategies that shape the future of medicines.

Main responsibilities :

• Collaborate closely with cross-functional scientific teams in R&D and industrial operations (analytical development, drug substance and drug product process development, manufacturing) to collect and consolidate required data, in coordination with CMC regulatory affairs to define the appropriate regulatory strategy.
• Coordinate and facilitate meetings dedicated to the development of regulatory dossiers, defining their structure and content in compliance with quality and regulatory requirements, while ensuring adherence to project timelines and key milestones.
• Contribute to the drafting, review, and ongoing maintenance of regulatory dossiers, ensuring their accuracy, consistency, and scientific integrity.
• Provide expert CMC scientific and regulatory guidance to address project-specific challenges and support decision-making across stakeholders.
• Represent the CMC Dossiers function in cross-functional meetings related to assigned projects.
• Ensure compliance of regulatory documentation with ICH M4Q (CTD), EMA and FDA requirements, as well as Good Manufacturing Practice (GMP) guidelines.

Requirements

Education: Master’s degree in life sciences, pharmacy, chemistry, or a related field, a PhD or PharmD is a plus.

Experience: Significant experience in CMC regulatory affairs within a pharmaceutical environment, with exposure to global submissions and lifecycle management activities; prior leadership or project management responsibilities are a plus.

Skills: Strong knowledge of CMC regulatory requirements, global submission processes, and post-approval changes, solid understanding of manufacturing, quality, and supply chain interfaces; excellent stakeholder management, leadership, and communication skills.

Languages: Fluent in English (written and spoken); additional languages are an asset.

Benefits

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.