Senior Scientist－Preclinical Safety
Core
Authoring Japanese New Drug Applications (J-NDAs) and providing pharmacology/toxicology expertise to support clinical programs and regulatory submissions in Japan.
Role type
Senior Scientist, Preclinical Safety (Regulatory & Toxicology)
Builds
Regulatory submission dossiers (J-NDAs) and clinical study documentation for Japan market
Domain
Life Sciences / Pharmaceutical / Regulatory Affairs / Toxicology
Deliverable
client delivery
Required skills
Pharmacology, Toxicology, GLP toxicology testing, Regulatory guideline knowledge, Japanese (native), English (fluent)
Preferred skills
Radiation therapy/gene therapy/cell therapy toxicity, Reproductive/developmental toxicity, Genotoxicity, AI-based toxicity assessment
Technologies
None explicitly stated
Responsibilities
Author responsible parts of J-NDAs and respond to PMDA inquiries; Assess pharmacological/toxicological profiles of early projects; Support clinical studies via protocol/ICF/IB review and interaction with Health Authorities; Ensure quality management and adverse event reporting
Seniority
Senior, hands-on IC
