Regulatory Officer
PSI CRO AGJapan
Posted November 18, 2025
Full Time
About the Company
PSI is a leading Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry.
Job Description
PSI is a leading Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry. As a Regulatory Officer, you will work closely with our global team of experts to prepare clinical trial dossiers for regulatory and authorities, deliver regulatory training to project teams, and communicate with stakeholders on regulatory-related matters.
Requirements
- University degree in Life Sciences, Medicine or Pharmacy or an equivalent combination of education, training, and experience
- Experience with clinical trial submissions to PMDA
- Knowledge of the regulatory environment for clinical research
- Full working proficiency in English and Japanese
- Detail-oriented
- Communication (Japanese and English), collaboration, and problem-solving skills
