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

[Remote Work] Japan Regulatory Affairs Specialist

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

Role overview

Qualifications

  • 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

Responsibilities

  • Partner with Country RA, AWC, QA, SMEs, and partner companies to ensure compliant artwork development
  • Collect SME input, prepare meeting materials, and join artwork/regulatory discussions
  • Provide RA comments, coordinate 2nd RA reviews, and manage regulatory submissions/approvals
  • Maintain organized SharePoint folder structure and ensure accurate filing of documents

Key facts

Hard skills

Other skills

  • Communication
  • Detail Oriented
  • Problem Solving

About the company

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

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

Staffing & Recruiting

➡️ HERE IS WHAT WE DO We specialize in searching for and recruiting top talent in the Pharmaceutical and Medical Device Industry in Japan (JPAC) and Asia (APAC) via our Japan and Singapore offices. ➡️ HOW DO WE GET THINGS DONE With nearly two decades of recruitment experience in the Pharmaceutical Industry in Japan and Asia, we have the client-relationship expertise, knowledge, persistence, dedication, and diligence to ensure even the most challenging recruitment searches are successful. ➡️ FOR HIRING MANAGERS Through our extensive contacts with the best, brightest, and most well-prepared candidates in the market, combined with the ability to fully understand our clients' needs, we can quickly provide the perfect solution to your requirements. ➡️ FOR JOB SEEKERS We take the time to listen, understand and present opportunities to you when you are ready. ➡️ WHERE HAVE YOU SEEN US Since 2006, Philip has been writing a monthly column for Pharma Japan. He has also been published in Life Science Leader, The Fordyce Letter and Biosimilar Development. ➡️ WHAT OTHERS SAY "Philip has exceptional knowledge of the Japanese Pharmaceutical Industry. Philip is also dedicated to advancing global business leaders’ knowledge and applied skills through his insightful articles. I have found the articles beneficial in both the business environment and as excellent discussion topics as part of the International Management course I teach at the University of Texas. I highly recommend Philip to support a company's efforts to advance their firm with a "Global Mindset" staff and practices". Scott Manning, Lecturer at San Diego State University and former Country Manager of Alcon Japan "Philip is extremely knowledgeable of the Japanese Pharma Industry and his articles are always very intriguing. He is certainly a person that can identify talent and professionals that could grow and add value to the hiring company" Masaki Nakanishi, Director of Business Development at AnGes, Inc.

Company details

Company typeTPE
IndustryStaffing & Recruiting
Company size11 - 50

Links

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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



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.

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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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