Clinical Regulatory Project Manager – France

TN France; France; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

Join a dynamic team at a leading mid-size CRO in France as a Clinical Regulatory Project Manager. You will play a vital role in driving innovation in clinical research, ensuring compliance with regulatory standards while fostering an inclusive environment for collaboration and growth.

Qualifications

• Experience in clinical regulatory affairs and managing global clinical trial authorizations.
• Strong understanding of regulatory requirements and compliance.

Responsabilités

• Coordinate submission and approval of clinical trial authorizations.
• Define global clinical regulatory strategy and oversee trial lifecycle.
• Lead regulatory conduct from start-up to close-out.

Connaissances

Regulatory Compliance

Project Management

Collaboration

Formation

Degree in Life Sciences

Description du poste

Clinical Regulatory Project Manager – France, France

Client: Excelya

Location: France

Job Category: Other

EU work permit required: Yes

Job Reference: 4634c2e82c5d

Job Views: 2

Posted: 18.05.2025

Expiry Date: 02.07.2025

Job Description:

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.

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 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

• Coordinate the submission, approval, and maintenance of global clinical trial authorizations (CTAs), ensuring compliance with regulatory and transparency requirements.
• Define the global clinical regulatory strategy in collaboration with regional regulatory leads when applicable.
• Prepare core regulatory and scientific documentation required for CTA submissions and amendments to Health Authorities (HAs) and Ethics Committees (ECs).
• Oversee the regulatory follow-up of clinical trials throughout their lifecycle.
• Act as Clinical Regulatory Affairs representative within Study Teams, supporting trial conduct with operational regulatory expertise.
• Define and implement the optimal clinical trial regulatory strategy to ensure protocol compliance and alignment with timelines.
• Lead and supervise the regulatory conduct of the trial from start-up through to study close-out.
• Identify, anticipate, and mitigate potential deviations or risks related to regulatory compliance during trial execution.
• Provide regular and accurate updates to Study/Core Teams and Global Regulatory Teams.
• Assess clinical studies as part of due diligence evaluations for business development or partnership opportunities.