MAH Importation Coordinator [Pharmaceuticals] - Remote, Japan

Location: Japan (Remote / On-site as required)

Company Overview 

A global life sciences regulatory and supply chain services organization supporting pharmaceutical and biotechnology companies with compliant product importation, regulatory operations, and commercialization activities in Japan. The organization works closely with overseas manufacturers, logistics partners, and local distributors to ensure products meet Japanese regulatory and quality requirements.

Role Overview

The MAH Coordinator will support end-to-end import operations for pharmaceutical products in Japan on behalf of client companies. The role ensures all inbound shipments comply with the Pharmaceuticals and Medical Devices Act (PMD Act), GQP/GDP standards, and Japanese customs regulations.

This position serves as a key coordination hub between clients, customs brokers, logistics partners, distributors, and internal regulatory and quality teams to ensure smooth, timely, and compliant importation activities.

Key Responsibilities

1. Pre-Import Preparation

• Collect, review, and manage import documentation, including invoices, packing lists, certificates of analysis (COA), MSDS, and shipping documents.
  

• Ensure documentation aligns with approved product information (SKU, strength, packaging configuration, manufacturer, and storage conditions).
  

• Coordinate with overseas manufacturing sites and shipping partners to confirm shipment readiness and documentation accuracy.
  

2. Customs Broker & Bonded Warehouse Coordination

• Act as the primary point of contact for customs brokers (CHA) and bonded warehouses.
  

• Share import documentation, confirm HS code classifications, and verify accuracy of customs declarations.
  

• Respond to customs-related inquiries and ensure required regulatory documentation is submitted in a timely manner.
  

3. Regulatory & Quality Compliance

• Ensure import activities comply with the PMD Act and applicable Japanese regulatory requirements.
  

• Verify that products originate from approved manufacturing sites.
  

• Coordinate with internal QA/QP and regulatory teams on release-related documentation and quality checks.
  

4. Shipment Tracking & Logistics Management

• Monitor inbound shipments (air and sea) and provide ETA updates to relevant stakeholders.
  

• Ensure cold-chain integrity and compliance with temperature-controlled logistics requirements.
  

• Coordinate product movement from port to bonded warehouse and onward to the distributor.
  

5. Warehouse & Post-Import Activities

• Confirm product quantities, batch numbers, and expiry dates upon receipt at the warehouse.
  

• Ensure GDP-compliant handling, documentation, and release procedures.
  

• Maintain complete, accurate, and audit-ready records of all import activities.
  

6. Stakeholder Communication & Reporting

• Serve as the communication bridge between clients, distributors, customs brokers, freight forwarders, and internal teams.
  

• Prepare and share import status updates, shipment reports, and issue logs.
  

7. Issue Management & Continuous Improvement

• Identify and report discrepancies, shipment delays, documentation gaps, or quality concerns.
  

• Escalate deviations, temperature excursions, or compliance issues to quality and regulatory teams.
  

• Support corrective and preventive action (CAPA) activities as required.
  

8. Vendor & Partner Management

• Monitor performance of logistics partners and customs brokers.
  

• Support onboarding, evaluation, or transition of new vendors when needed.
  

• Ensure external partners operate in accordance with GQP/GDP standards.
  

Requirements

• Bachelor’s degree in Supply Chain, Life Sciences, Pharmacy, or a related discipline.
  

• 3–7 years of experience in pharmaceutical importation, logistics, regulatory operations, or MAH support (Japan experience preferred).
  

• Working knowledge of PMD Act requirements, GQP/GDP frameworks, and Japanese customs procedures.
  

• Experience coordinating with customs brokers, freight forwarders, and GDP-compliant warehouses.
  

• Strong communication skills in English and Japanese (written and verbal).
  

• Ability to manage multiple shipments and stakeholders under tight timelines.
  

Key Competencies

• Strong regulatory awareness and attention to detail
  

• Excellent coordination, follow-up, and documentation discipline
  

• Problem-solving and issue escalation capability
  

• Effective stakeholder and vendor management
  

• Ability to operate in a fast-paced, cross-functional environment
  

Benefits