[Remote Work] Japan Regulatory Affairs Specialist - Artwork Development

Key Responsibilities1. General RA & Cross-Functional CoordinationPartner 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 QACoordinate internal reviews (e.g., Marketing, ExM).Support CRA on Market Approval and notify QA for overseas approvals.4. Workflow ObsoletionGather 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 ManagementMaintain 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.RequirementsTechnical 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 controlsSoft 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 skillsBenefitsRemote Work / Improved work-life balanceOpen for Junior candidates as well (This role will allow the person to gain experience while supporting the main person in charge.)Competitive SalaryWork in an international / Global environment

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