[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