SSU Regulatory Manager

Excelya; Paris; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A dynamic clinical research company in Paris is seeking a Clinical Operations professional to lead study start-up activities. Key responsibilities include ensuring regulatory compliance, coordinating with local teams, and maintaining clinical trial systems. The ideal candidate possesses a Bachelor's degree in a life science and expertise in clinical trial management. Proficiency in French and English is essential. Join our ambitious team and help drive innovation in healthcare.

Qualifications

• Experience in preparing and managing regulatory and ethics submissions.
• Strong knowledge of ICH-GCP guidelines and relevant local regulatory requirements.

Responsabilités

• Lead and coordinate study start-up activities at the country level.
• Prepare, collect, review, and track regulatory documents.
• Ensure timely submission and approval of study documentation.
• Collaborate closely with CRAs and Local Study Team.
• Maintain and update clinical trial tracking systems.
• Participate in Local Study Team meetings.
• Follow up with sites to resolve documentation issues.
• Perform quality control checks on essential documents.
• Provide feedback on local site / investigator feasibility.

Connaissances

Clinical development process understanding

Study start-up expertise

Clinical trial management knowledge

ICH-GCP guidelines knowledge

CTMS proficiency

eTMF proficiency

Fluent in French

Fluent in English

Formation

Bachelor's degree in a life science or related discipline

Description du poste

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 Clinical Operations. 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 :

• Lead and coordinate study start-up activities at the country level in accordance with internal procedures, ICH-GCP guidelines, and local regulatory requirements
• Prepare, collect, review, and track regulatory documents for Regulatory Authority and Ethics Committee submissions
• Ensure timely submission and approval of study documentation during start-up and regulatory maintenance phases
• Collaborate closely with CRAs and Local Study Team to achieve start-up milestones on time
• Maintain and update clinical trial tracking systems (e.g., CTMS, eTMF) throughout the start-up phase
• Participate in Local Study Team (LST) meetings and provide regular updates to country line managers
• Follow up with sites to resolve outstanding documentation issues and prepare sites for activation
• Perform quality control checks on essential documents to ensure compliance with ICH-GCP and company SOPs
• Provide feedback on local site / investigator feasibility and competing studies for local market insights

Requirements

Experience : Experience in preparing and managing regulatory and ethics submissions

Skills : Solid understanding of the clinical development process , with specific expertise in study start-up and clinical trial management, strong knowledge of ICH-GCP guidelines and relevant local regulatory requirements, proficient in using clinical trial management systems (CTMS) and electronic Trial Master Files (eTMF).

Education : Bachelor's degree in a life science or related discipline (or equivalent qualification).

Languages : Fluent in French and English.

Benefits

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.