Senior Regulatory Affairs Specialist H/F - 75

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.AbouttheJob

JoinExcelya,whereAudacity,Care,andEnergydefinewhoweareandhowwework.Webelieveincreatingboldsolutionsandfosteringaninclusiveenvironmentwherecollaborationandindividualgrowthgohandinhand.

Thisroleisanexcitingopportunitytocontributetoadynamic,ambitiousteam.Youwillplayacriticalpartindrivinginnovationandmakinganimpactintheclinicalresearchspace,whileenjoyingastimulatingprofessionalenvironmentthatencouragespersonalandintellectualgrowth.

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.