Regulatory Affairs Associate

Tokyo, Tokyo N/a

Posted: 01/29/2026 Employment Type: Direct Hire/Perm Job Category: Regulatory Affairs Job Number: 625203 Is job remote?: Hybrid Country: Japan

Job Description


Job Title: Regulatory Affairs Associate
Location: Japan

Role Overview

A life sciences organisation is seeking a Regulatory Affairs Associate to provide hands-on administrative and documentation support to the Regulatory Affairs function in Japan. This role is well suited to a detail-oriented professional with strong bilingual documentation skills who is comfortable working with English and Japanese regulatory materials.

The position plays a key supporting role in regulatory project coordination, documentation quality, and submission readiness, working closely with senior regulatory leadership and cross-functional teams.

Key Responsibilities

  • Provide day-to-day administrative and coordination support for regulatory projects, including responding to internal and external queries

  • Format regulatory documents in both English and Japanese in line with established templates, style guides, and regulatory standards

  • Support preparation, review, and quality control of XML files for regulatory submissions

  • Assist with document uploads and submissions via the PMDA Gateway in accordance with internal procedures and regulatory requirements

  • Prepare, maintain, and archive regulatory contact reports to ensure accurate documentation and traceability of communications

  • Draft clear and accurate meeting minutes in both English and Japanese, capturing key discussions, decisions, and action items

  • Maintain organised records of regulatory documentation and correspondence with health authorities

  • Perform quality checks on regulatory documents, ensuring grammatical accuracy, consistency, and uniform formatting across English and Japanese materials

Candidate Profile

  • Strong English reading, writing, and comprehension skills (basic spoken communication acceptable)

  • Native-level or highly proficient Japanese

  • Advanced Microsoft Word formatting capabilities

  • Experience performing quality control (QC) of bilingual (English/Japanese) documentation

  • Ability to review, refine, and improve machine-translated regulatory texts

  • High attention to detail with strong organisational and critical-thinking skills

  • Comfortable managing multiple tasks and working across functions in a regulated environment

Reporting & Collaboration

  • Reports directly to senior Regulatory Affairs leadership in Japan

  • Regular interaction with cross-functional teams to support interconnected regulatory and operational projects
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