薬事戦略マネージャー/ Japan Regulatory Strategy Manager

An international pharmaceutical company is searching for a Japan Regulatory Strategy Manager. The chosen applicant will develop and execute regulatory strategies for drug development and approvals. This is a remote work.

Responsibilities:

• Develop and implement the Japan regulatory strategy aligned with the global regulatory strategy, and provides guidance on local mechanisms to accelerate or optimise product development and approvals
• Lead the preparation and timely submission of regulatory documents in Japan, including NDAs, CTNs, briefing packages, and Orphan Drug Applications, ensuring compliance with local and corporate requirements
• Collaborates closely with Global Regulatory Lead to integrate Japan’s regulatory strategy into the global regulatory plan
• Acts as the primary interface with MHLW and PMDA for product approvals and clinical development, and leads strategy for Health Authority interactions
• Supports local planning and execution of clinical studies in accordance with Japan’s legal and regulatory requirements
• Proactively develops regulatory strategies and mitigates regulatory risks across RA Japan, while promoting process standardisation and simplification
• Engages with local trade associations to monitor national legislation and shape the external regulatory environment

Ensures regulatory compliance for all HA submissions and post-approval commitments, and contributes to country-specific compliance procedures and practices

Requirements:

• Bachelor’s degree or above (advanced degree is preferred)
• More than 10 years of directly related experience
• More than 5 years of experience in Regulatory Affairs
• In-depth regulatory experience
• Knowledge of Japan legislation and regulations relating to medicinal products
• Knowledge of drug development Scientific or Technical Excellence
• Ability to communicate scientific or clinical information
• Ability to work in matrix environments, including cross-functional and global teams
• Understanding of regulatory activities
• Ability to understand and communicate scientific and clinical information
• Proficient in MS Office
• Native level Japanese; proficient in English (TOEIC 860+ is desirable)

About the Company:

A global pharmaceutical group, this organisation is an internationally recognised name in biotechnology. Responsible for a range of medicines aimed at treating human illnesses, this company supplies medical professionals and patients across the world.

Keywords:

規制事務, 製薬, 医療, 経営, 外資系

Job Ref: TQ9VZV