CMCオペレーションサポート/ CMC Operation Support

A multinational life sciences company is looking for a CMC Operation Support. The chosen applicant will support document preparation, timeline and tracker management, RTQ follow-up, and EDMS data updates across regulatory and quality operations.

Responsibilities:

• Support the preparation of MCN and PCA packages, including document compilation, template application, formatting, and basic completeness checks
• Maintain project schedules, task lists, and trackers for GMP inspections, including PAI NDA, PAI PCA, and periodic reviews, together with FMA activities such as new applications, renewals, and notifications
• Support the monitoring of RTQs and responses, including owners, due dates, and status updates
• Maintain and update records in EDMS for MCN, PCA, approvals, GMP inspections, FMA, and other lifecycle events, working under supervision

Requirements:

• 1-3 years of experience in an operations-focused support role, such as operational support, coordination, administrative operations, shared services, or back-office operations within a pharmaceutical organisation
• Strong IT literacy, including MS Office/M365, Outlook, Excel, PowerPoint, Teams/SharePoint, and the ability to learn new internal systems quickly
• Ability to organise, track, and maintain information such as trackers, logs, meeting minutes, and action items with strong attention to detail and sound record-keeping practices
• Professional email writing, follow-ups, summaries, status updates, and accurate documentation of actions and decisions
• Proficient in Japanese and English

About the Company:

A global life sciences company providing regulatory, quality, and compliance solutions to the pharmaceutical and biotechnology industries. The organisation supports clients worldwide with expertise across the product development and commercialisation lifecycle.

Keywords:

医療, 製薬, ライフサイエンス, 業務, サポート, 管理, 外資系

Job Ref: Q5BZ4W