[DJ] 非臨床開発研究部 [DSRD] リサーチアンドディベロップメントサイエンティスト（専門管理職・一般社員）/Research and Development Scientist （Research & Development Scientist / DSRD-Tokyo）
Core
Lead non-clinical regulatory affairs and strategy for pharmaceutical approvals in Japan, managing toxicology, pharmacology, and pharmacokinetics data for regulatory submissions.
Role type
Senior IC Regulatory Scientist (Non-Clinical)
Builds
Regulatory documents (IB, CTD) and non-clinical development strategies for Japan
Domain
Pharmaceutical industry, Regulatory Affairs, Non-clinical research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Non-clinical regulatory document creation, Toxicology, Pharmacology, Pharmacokinetics, Regulatory strategy planning, Risk management, Scientific knowledge of new modalities, Regulatory guideline interpretation
Preferred skills
Global regulatory submission experience, Animal experiment execution, Cross-functional collaboration, Open innovation partnership building
Technologies
CTD, IB, CTPN, PMDA systems
Responsibilities
Create and review non-clinical regulatory documents (IB, CTD) for PMDA submissions, Develop and execute Japan-specific non-clinical development and risk management strategies, Represent the department in meetings with regulatory authorities (PMDA), Monitor global non-clinical trial progress and provide updates to project teams, Collaborate with global teams to adapt international guidelines to Japanese regulations, Build open innovation opportunities by sharing Japan's scientific landscape with global R&D
Seniority
Senior, hands-on IC
