Responsable Conformité Réglementaire Qualité H/F – CDI Chatillon sur Chalaronne
Core
Regulatory Compliance Manager ensuring product quality and regulatory adherence for pharmaceutical manufacturing.
Role type
Senior Regulatory Compliance Manager
Builds
Regulatory dossiers (Module 3), variation filings, and official responses for new product registrations.
Domain
Healthcare / Pharmaceuticals / Regulatory Affairs
Required skills
GMP/BPF knowledge, AMM dossier expertise, risk analysis, regulatory strategy, documentation management
Preferred skills
English fluency, stakeholder coordination, investigation support
Technologies
GMP, BPF, CSP, ICH, AMM
Responsibilities
Draft technical parts of marketing authorization applications, coordinate variation filings, respond to regulatory authority inquiries, maintain regulatory documentation, participate in product reviews.
Seniority
Senior, hands-on IC
