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Regulatory CMC Expert (manager), Japan

CSL
Full time Japan, Tokyo Other Management Occupations
Posted:
March 02, 2026
Location:
Japan, Tokyo, Japan

Job Description

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...

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    Job Overview

    Job Type: Full time
    Location: Japan, Japan
    Posted: March 02, 2026
    Deadline: April 11, 2026