Regulatory Compound Leader

場所: 東京都, 日本
給与: ¥7000000 - ¥10000000 per annum + incentive
セクター: 薬事申請
ジョブタイプ: 正社員




・Lead Japanese regulatory strategy and target labeling , and share the information to the Global Regulatory Team

・Lead CTD Preparation Team for J-NDA submission

・Lead HA response such as PMDA consultation/ preliminary meeting, MHLW meeting for orphan designation, 30 (14) Day review for J-CTN regarding Development plan and submission

・Negotiate with Japanese Health Authorities (HA) regarding development compound


・Minimum of bachelor's degree or equivalent in pharmacy or life-science or health-related discipline

・Minimum of 6 years of overall experience in R&D in pharmaceutical industry (including 2+ years of regulatory experience) or in health authorities OR Masters/PharmD and 4+ years, PhD and 2+ years

・Leadership and contribution to drug development strategies

・Knowledge of regulations in Japan

・Good verbal and written communications skills in Japanese and decent English skills

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