Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role offers an exciting opportunity to support the systems used for clinical data collection and management in clinical trials. As a Business System Expert, you will act as the bridge between Clinical Data Management, IT, QA, and system vendors, ensuring the performance, compliance, and continuous improvement of Oracle Clinical One and related EDC platforms.

Key Responsibilities

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role offers an exciting opportunity to support the analytical platforms used for the design and statistical analysis of clinical trial data. As a Business System Expert, you will act as the link between Biostatistics, Statistical Programming, IT, QA, and external vendors, ensuring the performance, compliance, and continuous improvement of critical clinical systems.

Key Responsibilities

Join Excelya, a dynamic and innovative company committed to excellence and collaboration in the field of translational research.Our global team of experts are the powerful force behind our success. When you work at Excelya, you become part of an international network that nurtures your talent, builds your skills and recognizes your value.

The selected consultant will play a critical role in leading the global Regulatory CMC strategy for a small molecule product, with a particular focus on Module 3 preparation, Marketing Authorization Applications, global health authority interactions, and regulatory submission readiness

Missions

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

As part of our activities, we are looking for an experienced Senior Project Manager Clinical Systems to support one of our pharmaceutical partners in the framing and assessment of digital initiatives within Clinical Development.

Within the Clinical System Management department, you will support initiative sponsors during the Opportunity and Feasibility phases, prior to project implementation.

Key responsibilities :

• Clarify the business needs, objectives and expected value of new initiatives.
• Identify and map impacted business processes, systems and stakeholders.
• Lead workshops with Business, IT and senior stakeholders.
• Assess project feasibility, risks, dependencies and key success factors.
• Define required resources, budget estimates and governance.
• Develop high-level project roadmaps and recommendations.
• Deliver structured project framing and feasibility documentation to support decision-making.

Requirements

Education : Master’s degree or equivalent in Life Sciences, Engineering, Information Systems, Project Management, Business or a related field.

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role offers an exciting opportunity to support a strategic productivity initiative within a leading pharmaceutical R&D environment. As a Data Manager – Efficiency Engine, you will contribute to improving operational efficiency, optimizing data workflows, and implementing automation solutions to accelerate project delivery within Research and Translational Medicine activities.

Key Responsabilities :

Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do.

As a Clinical Scientist, you will support the Study Medical Manager in the planning, execution, analysis, and reporting of clinical studies from study start-up through study close-out. You will contribute to protocol development, medical data review, study documentation, and cross-functional collaboration to ensure high-quality clinical trial delivery in compliance with regulatory requirements.

Key Responsibilities

Rejoignez Excelya, où Audace, Bienveillance et Énergie sont au cœur de notre façon de travailler. Nous croyons en des solutions innovantes et en un environnement inclusif où collaboration et développement professionnel vont de pair.

Dans le cadre d'un projet stratégique de l'industrie biopharmaceutique, vous contribuerez à la qualification, au démarrage et à la mise en exploitation d'un nouveau site de production d'antigènes.

Dans le cadre de projets de transfert de production de formes liquides orales, nous recherchons un(e) Expert(e) MSAT Procédés Liquides pour accompagner les activités de transfert technologique et apporter son expertise technique et scientifique sur les procédés de fabrication et de conditionnement.

Intégré(e) au sein d'un département MSAT sur un site pharmaceutique à Toulouse, vous interviendrez comme référent(e) procédés et travaillerez en étroite collaboration avec les différentes équipes.

Missions Principales :

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.

The main objectives of this role are to lead the CMC Regulatory strategy of a small molecule asset (late phase; MAA under preparation) within a truly global scope and to manage and deliver the CMC Dossier with the support of the technical writing team within the Regulatory CMC.

Main Responsibilities:

Rejoignez Excelya, où Audace, Bienveillance et Énergie sont au cœur de notre façon de travailler. Nous croyons en des solutions innovantes et en un environnement inclusif où collaboration et développement professionnel vont de pair.

Dans le cadre d'un projet stratégique de l'industrie biopharmaceutique, vous contribuerez à la qualification, au démarrage et à la mise en exploitation d'un nouveau site de production d'antigènes.

En tant que Technicien de Bioproduction, vous serez en charge des missions suivantes.

Missions Principales :

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.

Provide operational regulatory support to a pharmaceutical affiliate in Greece, with primary responsibility for the maintenance and lifecycle management of national Marketing Authorisations (MAs), particularly for an oncology product. The role also supports regulatory activities across several European distributor markets.

Main Responsibilities: