CMC Dossier Preparation Specialist

About the Position

Excelya is seeking a CMC Dossier Preparation Specialist to join our dynamic team. In this role, you will be responsible for the preparation and management of Chemistry, Manufacturing, and Controls (CMC) documents for regulatory submissions. Your contributions will play a crucial role in ensuring compliance with regulatory requirements and supporting the development and lifecycle management of pharmaceutical products.

Your expertise will not only facilitate the timely submission of high-quality CMC documentation but will also help ensure that our products adhere to the highest standards of quality and regulatory compliance.

Main Responsibilities:

• Act as CMC dossier lead, coordinating inputs from multiple internal and external stakeholders
• Manage and update CMC Quality documentation related to:
• Drug Substance (API)
• Drug Product (injectable finished products)
• Stability studies
• Characterization activities
• Support clinical documentation updates, including amendments
• Contribute to and support regulatory submission dossiers (registration files)
• Provide CMC expertise related to:
• Antibody production
• Antibody characterization
• Injectable drug products
• (Optional) interface with device-related topics
• Lead and facilitate meetings, often with U.S.-based teams, ensuring:
• Active listening
• Alignment of perspectives
• Clear conclusions and consensual decisions
• Ensure clear synthesis, documentation rigor, and proactive follow-up of actions

Candidate Profile:

• Experience: Previous experience in CMC regulatory affairs or relevant pharmaceutical role, with a proven track record in dossier preparation for regulatory submissions.
• Skills: Strong knowledge of CMC Quality for biologics, including Drug Substance & Drug Product and Stability and characterization
• Education: Bachelor’s or Master’s degree in pharmaceutical sciences, life sciences, or a related field.
• Languages: Proficiency in English is essential; additional language skills are a plus.
• A proactive and collaborative approach with the ability to work effectively in cross-functional teams.

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.