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[Remote Work] Japan Regulatory Affairs Specialist - Artwork Development

100% remote Flexible hours Hiring now

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 reputed company/Tier-1 reputed company 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.
  • reputed company 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 reputed company 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

Remote Work / Improved work-life balance Open for Junior candidates as well (This role will allow the person to reputed company experience while supporting the main person in charge.)Competitive Salary Work in an international / Global environment Apply To This Job

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