ラベリング＆アートワークマネージャー/ Labelling & Artwork Manager

A global pharmaceutical company is looking for a Labelling & Artwork Manager. The selected candidate will oversee the end-to-end management of Japanese labelling and artwork processes in alignment with local regulations and global standards.

Responsibilities:

• Create, update, and maintain Japanese package inserts based on CCDS, RTQs, and latest regulatory templates
• Support competitive labelling analysis and contribute to Target Company Core Labelling Profile (TCLP) in collaboration with global leads
• Serve as the main point of contact for Japan labelling across internal and external stakeholders
• Drive operational excellence in labelling processes, including tracking and system updates
• Lead linguistic reviews, coordinate regulatory submissions, and ensure compliance with approved labels
• Lead the Local Labelling Committee and manage cross-functional label creation and approvals
• Act as the key contact for Japan artwork processes and ensure alignment with internal and external partners
• Build strong cross-functional relationships within Japan and with global regulatory teams
• Monitor and communicate updates to Japanese regulatory requirements for labelling and artwork

Requirements:

• Bachelor’s degree or above
• Proven experience in regulatory affairs, labelling, or artwork management
• Skilled in stakeholder management, communication, and cross-functional leadership
• Strong analytical, organisational, and risk management skills
• Professional level Japanese and English

About the Company:

A global pharmaceutical organisation that delivers cutting-edge products and services to meet patient needs. With employees in several countries, this is an excellent company to work for.

Keywords:

ラベリング, パッケージインサート, 規制対応, 医薬品, アートワーク, 翻訳レビュー, 承認プロセス, 薬事, マルチステークホルダー対応, 求人, 外資系

Job Ref: 0TJ1UG