[Remote Work] Japan Regulatory Affairs Specialist

Company Overview a global regulatory solutions and services company that supports life sciences and regulated product companies—especially pharma, biotech, medical device, consumer health, cosmetics, food & supplements, and chemicals—throughout the entire regulatory compliance value chain. Job Description 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 Remote Work / Improved work-life balance Open for Junior candidates as well ( This role will allow the person to gain experience while supporting the main person in charge.) Competitive Salary Work in an international / Global environment