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
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<会社情報>

世界約150か国、約4万人の従業員を擁するトータルヘルスケアカンパニー

<職務内容>

・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

<応募資格>

・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

To find out more about Real Staffing, please visit www.apac.realstaffing.com

Real Staffingについてもっと詳しく知りたい方はこちらへ→ www.apac.realstaffing.com/ja

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