Senior Scientist－Preclinical Safety Full-time

Regulatory Submission Expert

Drive regulatory submission excellence and early-stage development strategy by authoring high-quality Japanese New Drug Applications and providing pharmacology or toxicology expertise to clinical programs in Japan.

Major Accountabilities

• Authoring responsible parts of J-NDAs, response to PMDA and all of the other activities for submission if necessary.
• Assessment of pharmacological and/or toxicological profiles of early projects to contribute to Japan development strategy.
• Roles as JPT/JST members
• Support of TM clinical studies as pharmacologists and/or toxicologists including protocol/ICF review, IB review and interaction with HAs.
• Seeking opportunity of proposals about new development programs/ indications
• Participate/support initiatives, task-forces, and cross-functional activities in Dev./NPKK.
• Quality management responsibility
• Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures
• 100% timely delivery of all training requirements including compliance

Key Performance Indicators

• Appropriate quality and timing of NDA and post NDA activities
• Appropriate quality and timing of pharmacological and/or toxicological profiling/evaluation of early projects
• Appropriate quality and timing of study supports

Background

Education: MSc or PhD in life sciences (Pharmacology, toxicology, Pharmaceutics, other specific sciences), DVM/MD or equivalent professional experience.

Experience/Professional requirement:

Taking education or possessing knowledge of basic medicine, such as physiology, pharmacology, toxicology, anatomy/histology, molecular biology, etc.

For mid-carrier employee, experience in pharmacology, toxicology or relevant field of the pharmaceutical Industry, CRO, academia, etc.

English Skill:

Appropriate skills of English (read/write and oral)

Skills Desired

• Animal Models
• Bioinformatics
• Collaboration
• Data Analysis
• Ethics
• Problem Solving
• Regulatory Compliance
• Toxicology