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The Regulatory CMC Expert position at CSL Behring in Tokyo, Japan, seeks an experienced professional to evaluate and manage regulatory CMC aspects for both development and established pharmaceutical products. The role requires collaboration with global teams, preparation of regulatory dossiers, and effective communication with Japanese health authorities. Candidates should have a strong background in regulatory affairs, particularly within the Japanese pharmaceutical landscape.
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Job Summary
The Regulatory CMC Expert evaluates all CMC regulatory aspects related to 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 and at least 3 years of Regulatory CMC experience for development and/or established products.
Matching Summary
Match Score: 75
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The Regulatory CMC Expert position at CSL Behring in Tokyo, Japan, seeks an experienced professional to evaluate and manage regulatory CMC aspects for both development and established pharmaceutical products. The role requires collaboration with global teams, preparation of regulatory dossiers, and effective communication with Japanese health authorities. Candidates should have a strong background in regulatory affairs, particularly within the Japanese pharmaceutical landscape.
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Skills & Requirements
Must-have
CMC regulatory aspects evaluation
CMC strategy development and execution
Japanese CTD preparation
Japanese Health Authority interaction
Regulatory requirements interpretation
Nice-to-have
Collaboration with global teams
Technical guidance to specialists
Organizational values and operational excellence
Key Requirements
Bachelor’s degree in Life Science
At least 5 years pharmaceutical industry experience in CMC