Preclinical Regulatory, Manager
Preclinical Regulatory, Manager
Japan - Tokyo Apply Now
JOB ID: R-205112
LOCATION:
Japan - Tokyo
WORK LOCATION TYPE:
Flex Commuter / Hybrid
DATE POSTED: Jan. 15, 2025
CATEGORY: Regulatory
Job Summary
• Execute local preclinical documentation (Investigators Brochure for J-CTN, Briefing Document for PMDA consultation, and CTD preparation for J-NDA) and RTQs from Japan Health Authorities with Global Translational Science and Preclinical Development and manage outside service providers
• Bring local preclinical expertise to Japan Project Teams and Global Product Strategic Teams in Amgen
Key Activities
- Ensure quality of contents and of Japanese translation of preclinical parts in CTD for J-NDA and IB for J-CTN
- Input Japan-specific requirements for preclinical development to global members as a local expert
- Prepare and respond to preclinical questions for CTD and IB from PMDA with global members
- Interact with Japanese healthcare providers (PMDA, academic organizations, and National Institute of Health Science) to obtain acceptability of preclinical data for J-NDA of innovative medicines
- Interact with Key Opinion Leaders and/or Principle Investigators to convey preclinical knowledge of candidates (more of a focus area in Japan than in the west)
Knowledge and Skills
- Knowledge of preclinical science (toxicology, pharmacology, and/or drug metabolism)
- Knowledge for documentation (preclinical writing) and the quality of IB and CTD
- Knowledge of Preclinical regulations/guidelines (including GLP and ICH) in Japan
- Preclinical (toxicology, pharmacology, and/or drug metabolism) experiences in research lab
- Working in matrix environments as One Team
- Communication skills
- Negotiation skills to Japan Health Authorities
- English conversation, read, and writing
- Computers: Microsoft Outlook/ Word/ Excel/Power Point
Education & Experience (Basic)
- Master or Doctorate degree and 10 years of directly related experience
- Over total 5 years experiences with preclinical pharmacology, toxicology and/or drug metabolism for supporting CTN and NDA submission in Japan
- Over 5 years experiences in pharmaceutical industry
Experience (Preferred)
- Over5 NDA submissions and approvals in Japan (more preferred biologic experience)
