Expert Affaires Réglementaires F/H
Core
Specialized expert in pharmaceutical advertising control and marketing authorization (AMM) registration.
Role type
Senior regulatory affairs specialist (pharmaceutical advertising & AMM)
Builds
Promotional and non-promotional support materials; national and European AMM dossiers (variations, renewals)
Domain
Pharmaceutical industry + Regulatory affairs
Required skills
Pharmaceutical advertising compliance, AMM dossier preparation, European regulatory documentation, stakeholder advisory, training delivery, export dossier tracking
Preferred skills
Product group management, medical delegate support, packaging text validation
Technologies
PGR, RMP, CIP, Blue Box
Responsibilities
Validate promotional and non-promotional support materials; Advise Marketing and Sales teams on communication strategy; Prepare and follow national and European AMM dossiers; Manage regulatory documentation (PGR, RMP, CIP, Blue Box); Train internal teams on pharmaceutical advertising