[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）

Pfizer · Tokyo, Japan

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Role summary

Pfizer seeks a Research and Development Scientist to lead nonclinical regulatory affairs in Japan, overseeing drug approval submissions, regulatory documentation, and alignment with global development strategies. The role involves expertise in pharmacology, drug metabolism, and toxicology across multiple therapeutic programs.

What they're looking for

Master's degree or higher in medicine, pharmacy, biology, or veterinary medicine
Knowledge of international regulatory guidelines and safety assessment practices
Proficiency in pharmaceutical regulatory document preparation and submission
English proficiency in written and verbal communication for business operations
Scientific expertise in new modalities and emerging therapeutic areas
Practical experience in pharmaceutical research and development
Experience with animal studies, toxicology testing, and global regulatory submissions

What you'll be doing

Provide nonclinical expertise (pharmacology, drug metabolism, toxicology) to development project teams in Japan
Prepare and submit nonclinical regulatory documents to PMDA and other authorities; respond to regulatory inquiries
Develop and execute nonclinical research strategy for Japan aligned with global development plans
Monitor global nonclinical study progress and communicate findings to internal teams
Identify scientific opportunities and build partnerships for open innovation with Japanese research institutions

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