RA アートワーク開発/ RA Artwork Development

A global life sciences consulting company is looking for an RA Artwork Development professional. The selected candidate will manage regulatory artwork workflows, documentation, and cross-functional coordination to ensure compliant and accurate delivery.

Responsibilities:

• Collaborate with CRA, QA, AWC, and stakeholders to ensure compliant artwork development
• Manage SharePoint structure, documentation, version control, and filing accuracy
• Support regulatory reviews and participate in Tier 1 and cross-functional meetings
• Initiate and manage artwork workflows in GLAMS, including approvals and communications
• Conduct QC checks to ensure accuracy, compliance, and alignment with regulatory standards
• Maintain documentation, archives, and structured data management across systems

Requirements:

• Bachelor’s degree or above
• Experience with GLAMS or other artwork management systems
• Knowledge of QRD, annotated PDFs, packaging components
• Prior regulatory knowledge (Japan artworks, labeling, packaging compliance)
• Proficient in file/document management (SharePoint)
• Skilled in interpreting regulatory decisions and change controls
• Professional level Japanese and English

About the Company:

A global leader in life sciences consulting, this company delivers regulatory, clinical, and quality solutions to support pharmaceutical, biotechnology, and medical device companies worldwide. Known for its innovative approach and deep domain expertise, it empowers job hunters to be part of impactful projects that advance healthcare and compliance on a global scale.

Keywords:

薬事、アートワーク管理、品質管理、文書管理、医薬品、規制遵守, 求人, 外資系

Job Ref: J04DZ0