Manage the preparation of dossiers for submission to regulatory authorities worldwide with a focus on Chemistry, Manufacturing and Control (CMC) aspects
Job Summary
Manage the preparation of dossiers for submission to regulatory authorities worldwide with a focus on Chemistry, Manufacturing and Control (CMC) aspects.
Write and manage technical sections of Module 3, assess documentary/technical gaps, and evaluate technical reports.
Conduct regulatory assessments for CMC change controls and interpret guidelines like GMP, ICH Q, and EMA Quality.
Matching Summary
Manage the preparation of dossiers for submission to regulatory authorities worldwide with a focus on Chemistry, Manufacturing and Control (CMC) aspects.
Skills & Requirements
Must-have
Chemistry, Manufacturing and Control (CMC)
Module 3 dossier preparation
Regulatory authorities worldwide
GMP, ICH Q, EMA Quality guidelines
Analytical chemistry
Manufacturing environment
Nice-to-have
Positive thinking and behaviour
Effective presentation and communication
Skilled in time management
Initiatives and self-motivation abilities
Key Requirements
3+ years working experience in CMC regulatory affairs