毒性学エキスパート/ Toxicology Expert

An international pharmaceutical company is looking for a Toxicology Expert. The selected candidate will evaluate toxicology data, ensure regulatory compliance, and support safe product development through clinical trials.

Responsibilities:

• Assess preclinical toxicology data to ensure volunteer and patient safety in clinical trials
• Ensure adequacy, scientific quality, and regulatory compliance of toxicology data packages
• Identify critical toxicological findings and propose mitigation or risk reduction strategies
• Prepare high-quality toxicology documentation for clinical trial initiation, PMDA consultations, and NDA submissions
• Respond to internal and external toxicology inquiries in collaboration with global teams
• Evaluate potential drug candidates from toxicology and regulatory perspectives during due diligence
• Contribute to global Preclinical Development (PCD) initiatives and cross-functional projects
• Mentor and develop junior staff in toxicology expertise

Requirements:

• Bachelor’s degree or above
• More than 3 years of experience in regulatory toxicology or experimental toxicology as laboratory staff or study monitor
• More than 5 years of experience in drug development in the pharmaceutical industry
• Experience in regulatory submissions for preclinical products (more than 2 products preferred)
• Prior experience in experimental toxicology across various industries
• Understanding of relevant regulations, guidelines, and GLP
• Skills for writing medical scientific documents in Japanese and English
• Proficient in reading and written English (TOEIC 650+)

About the Company:

A multinational pharmaceutical organisation originating out of Europe that is responsible for the research and development of several widely recognised pharmaceutical products as well as products related to diagnostic imaging, women’s health and adhesives among others.

Keywords:

毒性学, 前臨床, 安全性評価, 規制対応, 薬剤開発, 臨床試験, 求人, 外資系

Job Ref: FNN709