Regulatory Dossier Lead – EU/ICH, CMC
Enregistrez cette offre et organisez votre recherche
Créez un compte gratuit pour enregistrer des offres d'emploi, créer des alertes et revenir à cette liste depuis votre tableau de bord.
En continuant, vous acceptez nos Conditions d’utilisation & Politique de confidentialité.
Pauwels Consulting seeks an expert to lead regulatory dossier assessments and gap analyses for EU submissions, aligning with ICH and CMC requirements. You will identify risks, develop justifications, and shape remediation plans to support health authority responses.
The role demands 8+ years in pharma or life sciences, strong technical writing and stakeholder management, and fluency in English to communicate complex data clearly across cross-functional teams.
-
Research Associate Scientific Senior
Il y a 2 jours
Eigenbrakel, Waals-Brabant, Belgique Pauwels Consulting Temps plein 90 000 € - 120 000 € ContratOur client, a leading life sciences organization, is seeking an expert to lead comprehensive regulatory dossier assessments and file gap analyses. The project focuses on identifying compliance risks and developing scientific justifications to support regulatory submissions and health authority responses.Lead comprehensive gap analyses of regulatory dossiers...