非臨床薬理学/ Non-clinical Pharmacology

An international biopharmaceutical company is looking for a Non-clinical Pharmacology professional. The selected candidate will prepare and finalise non-clinical pharmacology submissions, engage with regulatory authorities, develop value propositions for new molecular entities, and support drug development strategies.

Responsibilities:

• Prepare and finalise non-clinical pharmacology documents for regulatory submissions in Japan
• Develop strategic plans for Japanese non-clinical documentation to differentiate products
• Manage documentation and review processes aligned with submission timelines
• Develop value propositions for new molecular entities from a biopharmaceutical perspective
• Prepare non-clinical pharmacology content supporting pricing claims and product differentiation
• Act as the interface between Japan teams and Global Discovery Research teams
• Obtain and communicate non-clinical data to strengthen product value propositions
• Propose and plan non-clinical studies to create meaningful differentiation from competitors and the standard of care
• Lead non-clinical studies where applicable
• Participate actively in development activities across Japan

Requirements:

• Doctoral Degree (PhD or MD in Biology and Pharmacology)
• More than 5 years of experience in pharmaceutical R&D
• 1-4 years of international experience
• Proven experience in regulatory science activities in non-clinical pharmacology
• Proven performance record across more than 10 drug development projects
• Knowledge of regulatory laws and guidelines in drug development
• Good connections with academia and regulatory authorities
• Fluent level Japanese and English

About the Company:

A global biopharmaceutical company focused on innovative drug development and healthcare solutions. The organisation operates internationally and collaborates across research, development, and regulatory functions to bring new therapies to market.

Keywords:

非臨床薬理, 薬理学, 創薬研究, 医薬品開発, 薬事申請, 規制科学, 新規分子化合物, バイオ医薬品, 研究開発, 求人, 外資系

Job Ref: RYR5DS