Regulatory Affairs Associate Promotion and Healthcare Compliance/ Validation

il y a 7 jours

Lyon, France Excelya Temps plein

**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:

- Ensure compliance of promotional and informational materials aimed at healthcare professionals and/or the general public (brochures, visuals, digital content, etc.)
- Work closely with marketing, medical, and legal teams to ensure regulatory alignment
- Ensure adherence to applicable regulatory and ethical standards (e.g., French Loi Bertrand, EFPIA Code, promotional guidelines)
- Contribute to the management and follow-up of clinical or regulatory projects
- Coordinate internal stakeholders (clinical, quality, pharmacovigilance, marketing) to ensure smooth project execution
- Assist with planning, milestone tracking, and reporting
- Monitor contracts, budgets, and deliverables to ensure quality and compliance
- Contribute to vendor audits and the continuous improvement of outsourcing processes
- Participate in regulatory intelligence activities (clinical trials, promotion, ethics, devices, etc.)
- Help draft and update internal procedures (SOPs)

**Requirements**:
Master's degree (or higher) in Life Sciences, Regulatory Affairs, or Pharmacy

Initial experience (internship or position) in regulatory or clinical affairs

Knowledge of EU regulations (EU Clinical Trials Regulation 536/2014, GCP, EMA, ANSM) and promotional compliance rules

Strong project management and cross-functional collaboration skills

Organized, detail-oriented, and a team player

Fluent in English (written and spoken)

**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.

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