CMC Regulatory Expert Biopharma - #47656

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 :

Define and lead the CMC regulatory strategy for complex projects, providing proactive guidance and expertise to cross-functional technical teams

Develop and maintain a global regulatory roadmap, ensuring alignment between manufacturing changes, regulatory requirements, and supply chain constraints

Oversee the preparation and submission of CMC dossiers, ensuring the robustness of comparability, validation, and quality data

Coordinate global regulatory submissions, optimizing timelines and ensuring compliance with regional requirements

Lead and manage interactions with Health Authorities, including addressing technical questions and supporting negotiations to facilitate approvals

Collaborate closely with Technical Operations, Quality, and Supply Chain teams to anticipate risks, support industrial transitions, and ensure global regulatory compliance

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 or biotech 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, including Module 3, 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.