Conduct change control of approved products appropriately as CMC-regulatory affairs (CMC-RA) and prepare application dossiers for CMC part to contribute in obtaining regulatory approval
Job Summary
Conduct change control of approved products appropriately as CMC-regulatory affairs (CMC-RA) and prepare application dossiers for CMC part to contribute in obtaining regulatory approval.
Collaborate with global and local stakeholders related to CMC-RA activity in Japan and prepare, review, and conduct QC of the CMC part of the dossier.
Prepare and reply to CMC questions from PMDA, and communicate directly with PMDA officials, while potentially being in charge of new drug applications.
Matching Summary
Conduct change control of approved products appropriately as CMC-regulatory affairs (CMC-RA) and prepare application dossiers for CMC part to contribute in obtaining regulatory approval.
Skills & Requirements
Must-have
CMC-regulatory affairs
prepare application dossiers
communicate with Health Authorities
change control activities
regulatory assessment
develop regulatory strategy
Nice-to-have
continuous manufacturing
antibodies
cell & gene therapy products
GMP-related regulations knowledge
Key Requirements
3-5 years CMC experience (Scientist)
8 years CMC experience (Manager)
Experience in change control operations
Experience in CTD and application form preparation