Manage the preparation of dossiers for submission to regulatory authorities worldwide by focusing on Chemistry, Manufacturing and Control (CMC) aspects
Job Summary
Manage the preparation of dossiers for submission to regulatory authorities worldwide by focusing on Chemistry, Manufacturing and Control (CMC) aspects.
Assess documentary/technical gaps, evaluate technical reports, and translate them into regulatory documents suitable for submission.
Develop and execute regulatory strategies in collaboration with cross-functional teams for technology transfers and complex CMC lifecycle projects.
Matching Summary
Manage the preparation of dossiers for submission to regulatory authorities worldwide by focusing on Chemistry, Manufacturing and Control (CMC) aspects.
Skills & Requirements
Must-have
Chemistry Manufacturing and Control (CMC)
Module 3 dossier preparation
regulatory authorities worldwide
Gap Analysis
Process Validation Reports
Analytical Methods Validation
GMP ICH Q EMA WHO guidelines
Nice-to-have
Positive thinking and behaviour
Effective presentation and communication skills
Skilled in time management
Initiatives and self-motivation abilities
Key Requirements
7+ years working experience in CMC regulatory affairs
Degree of chemistry, pharmacist or biotechnology
Previous experience in the management of tech transfers from a RA CMC perspective