規制スペシャリスト/ Regulatory Specialist

An international healthcare company is seeking a Regulatory Specialist. The selected candidate will prepare, submit, and manage regulatory documentation in compliance with chemical and agrochemical regulations, supporting both domestic and global projects. This is a hybrid role.

Responsibilities:

• Prepare and submit high-quality regulatory dossiers and related documentation
• Support CSCL compliance by developing regulatory strategies, liaising with clients and laboratories, and negotiating with authorities
• Provide consultation and registration support for EU, UK, and Korea REACH operations in Japan
• Conduct literature searches and prepare review reports using JMAFF databases
• Compile dossiers for agrochemical registration in accordance with JMAFF requirements
• Manage project timelines, budgets, and deliverables while maintaining commercial awareness

Requirements:

• Bachelor’s degree or equivalent in scientific domain
• More than 3 years of experience specialising in an appropriate regulatory discipline
• Experience in preparing EU/ global regulatory applications and project managing complex
  regulatory projects (Chemicals, Biocides and Crop Protection)
• Prior experience with registration-related tasks is a plus
• Proven experience in either the CSCL or REACH is ideal
• Understanding of chemicals
• Business level reading, written, and verbal Japanese and English

About the Company:

A global leader in healthcare and life sciences, this organisation drives innovation through advanced laboratory testing and cutting-edge diagnostic solutions. With a strong presence in Japan, it offers professionals the opportunity to contribute to groundbreaking research that improves patient outcomes worldwide.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系

Job Ref: JJMWPY