Key Responsibilities:
Dossier Assembly: Compiling, formatting, and preparing registration dossiers, renewals, and variation packages.
Database Archiving: Uploading approved certificates, health authority letters, and final labels into the internal tracking database.
Versatile Support: Shifting operational support between different regions of Emerging markets depending on launch volumes and pipeline deadlines.
Expectations:
Experience: 3 to 6 years in regulatory affairs.
Knowledge of ICH guidelines and relevant regulations in Emerging markets
Formatting Skills: Familiarity with compiling basic submission formats (like CTD, ACTD or local formats).