The CMC role ensures consistency and completeness of CMC data from drug development through regulatory approval
Job Summary
The CMC role ensures consistency and completeness of CMC data from drug development through regulatory approval.
Key responsibilities include establishing the CMC roadmap, managing timelines, and conducting technical reviews of data.
GC녹십자 is seeking candidates with a strong understanding of CMC development and commercialization, and the ability to perform technical writing in English.
Matching Summary
The CMC role ensures consistency and completeness of CMC data from drug development through regulatory approval.
Skills & Requirements
Must-have
CMC timeline creation and management
CMC gap analysis and filling
CTD module 3 authoring
Technical writing in English
Nice-to-have
Experience with regulatory agencies
Process Design and Validation experience
Strong English technical writing/speaking
Key Requirements
Bachelor's degree or higher
Major in Life Science, Bio, Chemistry, Medicine, or Pharmacy
Experience with CMC development and commercialization