Regulatory Affairs Specialist – Artwork Development

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🕒 March 25

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Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC)

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2011

💊 Pharmaceuticals

⚕️ Healthcare Insurance

🎯 Recruiter

Pharmaceuticals • Healthcare Insurance • Recruitment

Morunda is a recruitment firm specializing in connecting multinational companies within the pharmaceutical and medical device industries with top talent in Japan and Asia-Pacific. With over 75 years of combined experience, Morunda focuses on placing senior-level professionals and aiding in market entry strategies, ensuring that organizations find the right candidates to drive success in the healthcare sector.

📋 Description

• 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. • 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. • 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. • 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. • 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

• 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

🏖️ 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