Regulatory Affairs Specialist

il y a 4 jours

BoulogneBillancourt, France Excelya Temps plein

**About the Job**

Join Excelya as a **Regulatory Officer** **& Promotional Information**, 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.

**Regulatory Review of Drug Advertising in France**:

- Consulting on the promotion of medicinal products and/or medical devices
- Management of promotional, environmental, or corporate documents related to pharmaceutical companies
- Review and regulatory validation of promotional materials, in compliance with the French Public Health Code (CSP) and ANSM guidelines
- Expert assistance with the review, submission, and approval of promotional materials

**Requirements**:
**About you**

We are looking for a dynamic and team-oriented professional with solid experience in regulatory review of pharmaceutical advertising.

**Experience**:Hugeexperience in regulatory affairs or related roles within the pharmaceutical industry. Proven track record in reviewing and validating promotional materials in compliance with French regulations (CSP, ANSM guidelines). Experience in analyzing clinical trial data to support promotional claims. Exposure to both pharmaceutical advertising and medical device promotion is a plus.

**Skills**:Strong understanding of regulatory requirements and promotional guidelines. Comfortable managing both internal and external stakeholders. Skilled negotiator, particularly in marketing-related discussions. Demonstrates initiative, adaptability, and team spirit in a cross-functional environment.

**Education**:Degree in Pharmacy, Life Sciences, Regulatory Affairs

**Languages**:Fluent in French - professional proficiency in English required.

**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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