Senior Regulatory Affairs Specialist

il y a 1 jour

Paris, 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. 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.

**Key Responsibilities**:

- Provide regulatory advice on the promotion of medicinal products and/or medical devices.
- Manage and review promotional, environmental, and corporate materials for compliance with the French Public Health Code (CSP) and ANSM guidelines.
- Ensure regulatory validation of advertising and promotional content.
- Support certification of promotional information activities and provide guidance on transparency requirements (LEA).
- Conduct pre-inspections and audits of providers.
- Assess compliance of events, including hospitality and contracts.
- Deliver expert consulting and support to internal teams and external stakeholders.

**Requirements**:
**About You**
At Excelya, taking audacious steps is encouraged, so we're looking for individuals who are ready to grow with us and share our values.
- **Experience**: Proven experience in Regulatory Affairs, ideally with a focus on advertising/promotion in the pharmaceutical or medical device industry.
- **Skills**: Strong knowledge of French Public Health Code (CSP), ANSM guidelines, and applicable regulations, Excellent communication skills, with the ability to advise and influence cross-functional teams.
- **Education**: Degree in Life Sciences, Pharmacy, or related field
- **Languages**: Fluency in French & English is required

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