Job Details

Regulatory Affairs Manager – In-Country Caretaker (ICC)
Client: Internal PQE hiring (no external client)
Location: Fully remote, Japan

Company Overview

An established global life sciences consulting organisation is seeking an experienced Regulatory Affairs professional to join its Japan team.

The company operates internationally across pharmaceutical and medical device sectors and supports clients with regulatory, quality, and compliance services across multiple regions. With a diverse, multinational workforce and a strong global presence, the organisation delivers both local and cross-border regulatory solutions.

Due to continued growth in Japan, the company is expanding its In-Country Caretaker (ICC) capability.

Key Responsibilities
Responsibilities include, but are not limited to:

• Optimise and manage product registration processes to ensure regulatory compliance
• Compile, review, and maintain regulatory dossiers in line with applicable guidelines
• Ensure submissions are high quality and meet regulatory authority expectations
• Plan, coordinate, and execute regulatory activities throughout the product lifecycle
• Provide regulatory advice to clients for initial submissions and lifecycle maintenance of Master Files for foreign manufacturers
• Manage registration of foreign manufacturers of active substances, including:
  • Preparation, translation, and formatting of Japanese Master Files from English DMFs
  • Submission of Master Files to Japanese authorities
  • Liaison with Marketing Authorisation Holders
  • Communication with regulatory agencies (Japanese ? English)
  • Management of site accreditation activities
• Provide regulatory intelligence and updates on Japanese regulatory requirements
• Act as project manager for Japan-based regulatory projects (resource planning, budgeting, client coordination)
• Support business development activities for regulatory services in Japan

Nice to have:

• Experience supporting GMP audits
• Familiarity with EU and/or US registration processes

Candidate Requirements

• 5+ years’ experience in Regulatory Affairs within Japan
• Experience with API registration and/or In-Country Caretaker responsibilities preferred
• Strong knowledge of Japanese pharmaceutical regulations and guidance
• Previous project management experience
• Native-level Japanese and professional English proficiency

Culture & Environment
The organisation promotes a collaborative, performance-driven culture and invests in leadership development at all levels. Employees are encouraged to take ownership of projects, engage in international collaboration, and contribute to continued business growth.