Regulatory Affairs Market Specialist with French (all genders)

Merck KGaA · Warszawa

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Company
Merck KGaA
Location
Warszawa
Employment type
Full-time
Posted
July 14, 2026

About this job

You role: In this role, you will drive regulatory submission management for France, Belgium, and Luxembourg from initial planning through to final local execution. This includes managing complex dossier reviews and approvals, overseeing specialized Module 1 requirements, handling financial fee planning, and directing language-dependent activities such as localized cover letters, national Product Information, and artwork modifications. Beyond standard lifecycle management, you will actively champion early access programs (NPS/EAP) for new assets, support clinical trials, and partner cross-functionally to ensure strict quality control over all regulatory documentation and promotional materials.

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