At least 5 years pharmaceutical industry experience in cmc
The Regulatory CMC Expert evaluates all CMC regulatory aspects related to assigned products in Japan and develops strategies for life-cycle management
Job Summary
The Regulatory CMC Expert evaluates all CMC regulatory aspects related to assigned products in Japan and develops strategies for life-cycle management.
This role involves preparing CMC regulatory dossiers such as Japanese CTDs and acting as the primary contact point for negotiations with Japanese Health Authorities.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies in immunology, hematology, and other therapeutic areas.
Matching Summary
The Regulatory CMC Expert evaluates all CMC regulatory aspects related to assigned products in Japan and develops strategies for life-cycle management.
Skills & Requirements
Must-have
Japanese regulatory legislation expertise
Fluent Japanese and English communication skills
At least 5 years pharmaceutical industry experience in CMC
At least 3 years Regulatory CMC experience for development products
Experience with J-NDA, PCA, and MCN submissions
Nice-to-have
Advanced degree in Life Science or MBA preferred
Empathy with CSL values: Patient Focus and Innovation
Strategic thinking beyond borders and familiar contexts
Ability to lead gap analysis and propose remediation strategies
Key Requirements
Bachelor's degree in Life Science required
MSc, PhD, MD, or MBA preferred
Minimum 5 years pharmaceutical industry experience
Minimum 3 years specific Regulatory CMC experience
Fluency in written and spoken Japanese and English