CMC Regulatory Lead

Excelya; Boulogne-Billancourt; Sur place; EUR 50 000 - 85 000; Plein temps

Résumé du poste

Excelya recherche un professionnel passionné pour rejoindre son équipe dynamique en régulation CMC. Vous serez responsable de la stratégie réglementaire pour plusieurs modifications de cycle de vie des produits, tout en évoluant dans un environnement collaboratif qui encourage la croissance personnelle et intellectuelle.

Qualifications

• Aptitude à travailler dans des environnements collaboratifs et dynamiques.
• Fluence en anglais et en français requise.

Responsabilités

• Conduire la stratégie réglementaire CMC mondiale.
• Gérer toutes les responsabilités réglementaires CMC pour le portefeuille de ventes assigné.
• Anticiper les risques réglementaires et définir des plans d'atténuation.

Connaissances

Compétences analytiques

Capacités organisationnelles

Résolution de problèmes

Communication

Connaissance des réglementations pharmaceutiques

Formation

Connaissance approfondie des réglementations pharmaceutiques

Description du poste

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 offers an exciting opportunity to contribute to a dynamic, ambitious team in Regulatory. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

• Drive the global, risk-based CMC regulatory strategy for several complex life-cycle changes to marketed products.
• Act as the CMC regulatory point of contact within cross-functional project teams (Manufacturing, Quality, Supply, MSAT, etc.)
• Assess the regulatory impact of manufacturing changes and propose clear strategic recommendations.
• Coordinate the preparation and submission of CMC regulatory dossiers worldwide (post-AMM).
• Anticipate regulatory risks and define mitigation plans adapted to country / health authority requirements.
• Respond to questions from health agencies on CMC issues, in collaboration with technical functions.
• Manage all CMC regulatory responsibilities for the assigned sales portfolio, including associated pharmaceutical responsibilities.
• Monitor regulatory developments (ICH, FDA, EMA) and integrate them into proposed strategies.
• Participate actively in continuous CMC process improvement initiatives within the function.
• Work in an international environment and in close interaction with multidisciplinary global teams.

Requirements

At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.

• Experience: Proven ability to thrive in collaborative, fast-moving environments (we value talent most—no minimum years required!).
• Skills: Strong organizational abilities, problem-solving mindset, and excellent communication skills. Good knowledge of ICH, FDA, and EMA guidelines and requirements. Excellent analytical skills.
• Attributes: Organized, science-driven, pragmatic, and open-minded.
• Education: Strong knowledge of pharmaceutical regulations.
• Languages: Fluency in English and French.

Why Join Us?

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

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 talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.