[Remote Work] Japan Regulatory Affairs Specialist - Artwork Development

Key Responsibilities

1. General RA & Cross-Functional Coordination

• Partner with Country RA (CRA), AWC, QA, SMEs, and partner companies to ensure compliant artwork development.
  
• Manage SharePoint structure, documentation accuracy, and version control.
  
• Support CRA as 1st/2nd RA reviewer.
  
• Attend weekly Tier-1 meetings (facilitation in Jan/Apr/Jul/Oct) and bi-weekly meetings with local CRAs.
  

2. Pre-GLAMS (Preparation)

• Retrieve CRB/Tier-1 decisions and required inputs.
  
• Collect SME input, prepare meeting materials, and join artwork/regulatory discussions.
  
• Prepare QRD Checklists and Annotated PDFs for each artwork.
  

3. In-GLAMS (Workflow Execution)

• Determine workflow type (Concept / Mock-Up / Production) and initiate Artwork Request.
  
• Provide RA comments, coordinate 2nd RA reviews, and manage regulatory submissions/approvals.
  
• Monitor workflow notifications and address queries from PC, AWC, CRA, and SMEs.
  
• Perform regulatory QC to ensure:
  
  • Alignment with Annotated PDF & QRD
  
  • No unauthorized changes
  
  • Barcode encoding confirmed by QA
  
• Coordinate internal reviews (e.g., Marketing, ExM).
  
• Support CRA on Market Approval and notify QA for overseas approvals.
  

4. Workflow Obsoletion

• Gather required information for obsoletion cases.
  
• Initiate Obsolete Request workflow and upload justifications.
  
• Coordinate concurrence with impacted stakeholders (e.g., PC).
  
• Submit workflow with correct file linkage for automated retirement.
  

5. Documentation & Data Management

• Maintain organized SharePoint folder structure (Latest / Old Versions / QC Trail).
  
• Create structured folders using correct JP naming conventions.
  
• Ensure accurate filing of QRDs, annotated PDFs, supporting documents, and live-font artwork files.
  

Requirements

Technical Skills

· Regulatory knowledge (Japan artworks, labeling, packaging compliance)

· Experience with GLAMS or other artwork management systems

· File/document management (SharePoint proficiency)

· Understanding of QRD, annotated PDFs, packaging components

· Ability to interpret regulatory decisions and change controls

Soft Skills

· Strong stakeholder communication (internal teams, AWC, QA, partner companies)

· Detail-oriented and organized

· Ability to manage multiple workflows simultaneously

· Problem-solving and proactive follow-up

· Coordination and project-management skills

Benefits