Full time

Regulatory CMC Expert (manager), Japan

Posted by CSL • Japan, Tokyo, Japan

📍 Japan, Tokyo 🕒 March 01, 2026

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About the Role

Position Purpose: 
The Regulatory CMC Expert evaluates all CMC regulatory aspects related to the assigned products (including both development products and established products) in Japan.
The Regulatory CMC Expert develops and executes CMC strategies for development products/life-cycle management of established products collaborating with team members (e.g., Global Regulatory Leaders, Global Regulatory CMC, Regional Regulatory Representative).
The Regulatory CMC Expert prepares CMC regulatory dossiers (e.g., Japanese CTD) for development products and/or established products based on the global CMC documents (e.g., M3 documents /reports) in accordance with Japanese regulations and requirements.
The Regulatory CMC Expert prepares materials for negotiations, meetings, and consultations with Japanese Health Authorities for development products and/or established products.
The Regulatory CMC Expert oversees and interprets relevant existing or...
                

Job Details

Location Japan, Tokyo
Job Type Full time
Category Other Management Occupations
Posted March 01, 2026
Deadline April 10, 2026

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