CSL Behring is seeking a Regulatory CMC Expert (Manager) in Tokyo, Japan, to oversee regulatory aspects related to CMC for both development and established products. The ideal candidate will have substantial experience in the pharmaceutical industry, particularly in regulatory affairs and compliance
Job Summary
The Regulatory CMC Expert evaluates all CMC regulatory aspects related to the assigned products in Japan, developing and executing CMC strategies for development and established products.
This role involves preparing CMC regulatory dossiers, materials for negotiations with Japanese Health Authorities, and overseeing relevant regulatory requirements.
The position requires at least 5 years of pharmaceutical industry experience in CMC, with at least 3 years in Regulatory CMC for development and/or established products.
Matching Summary
Match Score: 85
CSL Behring is seeking a Regulatory CMC Expert (Manager) in Tokyo, Japan, to oversee regulatory aspects related to CMC for both development and established products. The ideal candidate will have substantial experience in the pharmaceutical industry, particularly in regulatory affairs and compliance.
Skills & Requirements
Must-have
CMC regulatory aspects
Japanese regulations and requirements
Japanese Health Authorities
Fluent Japanese and English communication
Nice-to-have
CSL values: Patient Focus, Innovation, Integrity, Collaboration, Superior Performance
Leadership Capabilities
Key Requirements
Bachelor’s degree in a Life Science
At least 5 years pharmaceutical industry experience in CMC