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 :

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 for a regulatory affairs Manager to lead strategic 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 healthcare products.

Main responsibilities :

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 contribute to a dynamic, ambitious team in Data Management. 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.

The Oracle Programmer is responsible for providing Oracle Programming input for Data Management activities dedicated to one Sponsor. They are responsible for ensuring all clinical programming aspects per Client’s SOPs are delivered to high quality.  

Main Responsibilities

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 contribute to a dynamic, ambitious team in Data Management. 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.

The Oracle Programmer is responsible for providing Oracle Programming input for Data Management activities dedicated to one Sponsor. They are responsible for ensuring all clinical programming aspects per Client’s SOPs are delivered to high quality.  

Main Responsibilities

About the Job

At Excelya, where Audacity, Care, and Energy are at the core of everything we do, we are seeking a Senior CMC Regulatory Consultant specializing in small molecules lifecycle management to join our dynamic team.

This role involves providing expert regulatory input throughout the lifecycle of small molecule products, from development to post-marketing activities. As a Senior Consultant, you will work closely with cross-functional teams to ensure robust regulatory strategies, compliance, and submission excellence.

Main Responsibilities:

Chez Excelya, nous sommes une équipe dynamique de plus de 900 professionnels passionnés, dédiés à devenir la CRO de taille intermédiaire leader en Europe. Nous offrons une expérience collaborateur unique dans un environnement stimulant et innovant.

Nous recherchons un(e) Technicien d'étude Clinique pour rejoindre notre équipe et contribuer au succès de nos projets cliniques en garantissant la qualité et la conformité des données recueillies.

Responsabilités

About the Job

Join Excelya as a Senior CMC Regulatory Technical Writer, 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.

You will play a key role in translating complex CMC scientific and technical data into clear, concise, and compliant regulatory documentation (Module 2.3 and Module 3 of the CTD), aligned with global health authority requirements.

This is a hands-on technical writing position working in close collaboration with CMC regulatory strategists and cross-functional technical teams (drug substance, drug product, analytical, manufacturing, QA). The role does not include regulatory strategy ownership but requires strong regulatory understanding.

Main Responsibilities:

À propos du poste

Rejoignez Excelya, où l'Audace, le Care et l'Énergie définissent qui nous sommes et la manière dont nous travaillons. Nous croyons en la création de solutions audacieuses et en un environnement inclusif, où la collaboration et le développement individuel avancent main dans la main.

Missions principales:

• Définir et mettre en œuvre la stratégie de biocompatibilité selon ISO 10993 et réglementations applicables (MDR, FDA si pertinent)
• Élaborer et maintenir le Biological Evaluation Plan (BEP) et le Biological Evaluation Report (BER)
• Identifier les essais nécessaires pour un dispositif implantable longue durée
• Assurer la cohérence scientifique et réglementaire de l’évaluation biologique
• Planifier, budgéter et suivre les activités d’essais
• Sélectionner et coordonner les laboratoires sous-traitants
• Superviser les échantillons de test avec les équipes R&D; et production
• Analyser et interpréter les résultats d’essais
• Rédiger et maintenir la documentation technique associée
• Contribuer au Technical Documentation / Design Dossier
• Garantir la conformité ISO 13485
• Contribuer aux investigations de non-conformités liées aux matériaux
• Renforcer le contrôle fournisseur sur les matières premières critiques
• Participer à l’amélioration continue du système qualité

Requirements

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.

You will be responsible for the medical assessment of sensitive pharmacovigilance files, often consisting of numerous medical documents. Expertise in neurology, obstetrics‑gynecology, or pediatrics is particularly valuable.

Your role will be to produce clear, accurate, and clinically rigorous medical summaries, supporting medico‑legal evaluations within the context of compensation requests.

Main Responsibilities:

About the Job

Join Excelya, where Audacity, Care, and Energy define how we support our clients and how we grow together. We believe in building bold solutions and fostering an inclusive environment where collaboration, responsibility, and personal development are central.

This role is an exciting opportunity to join our Clinical Quality Assurance team. As a key contributor, you will ensure that clinical research activities are conducted in full compliance with international regulations, internal standards, and industry best practices. You will help drive continuous improvement, strengthen our quality culture, and support teams through a stimulating and supportive professional environment.

Main Responsibilities: