Coordinator Regulatory Affairs (m/w/d) – Central America & Caribbean
Core
Coordinate regulatory submissions and dossier preparation for pharmaceutical products in Central America and the Caribbean.
Role type
Coordinator Regulatory Affairs
Builds
Regulatory dossiers and submission plans for pharmaceutical products
Domain
Pharmaceuticals / Regulatory Affairs
Required skills
Regulatory Affairs, Quality Assurance, Pharmacovigilance, Pharmaceutical Technology, Dossier preparation, Project management, Budget planning, Process optimization
Preferred skills
Spanish (B2), German (B2), AI tools usage, Stakeholder management
Technologies
EU-CTD formats, Regulatory databases
Responsibilities
Manage regulatory submissions and renewals, Prepare and update pharmaceutical dossiers, Maintain license certificate status, Build and manage partner networks, Optimize internal processes and documentation, Support capacity and budget planning