メディカル・バイオ - 薬事申請

Lead the identification of regulatory and legislative trends and issues that have the potential to impact the development and marketing of pharmaceutical products within Japan and provide high quality strategic input aimed at influencing the future regulation.
Japan Regulatory Policy Lead to engage in direct regulatory advocacy and influencing activities relating to regulatory healthcare policies partnering with stakeholders including local subject matter experts and AP/GRPI .
This is accomplished through a variety of activities, including participation in Trade Association initiatives, Health Authority meetings and consultation as well as contribution to commenting on new legislation and guidance.

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

REPORTING RELATIONSHIPS:

Japan Regulatory Affairs: Director, Japan RA TA-Group Leader

EDUCATION, EXPERIENCE & SKILL REQUIREMENTS:

Minimum of bachelor’s degree or equivalent in pharmacy or life-science or health-related discipline
Minimum of 8 years of overall experience in R&D in pharmaceutical industry (including 2+ years of regulatory experience) or in health authorities OR Masters/ PharmD and 6+ years, PhD and 4+ years
Working knowledge of regulations in Japan and/or experience of regulatory in product approval and licensing.
Excellent working knowledge of the regional regulatory framework and how that applies to pharmaceutical product development.
Excellent verbal and written communications skills in Japanese and English
Extensive experience in regulatory policy activities in industry or trade associations.
Experience in HAs interactions
Highly developed network amongst local regulators and other key associations and organizations.
Knowledge of regulatory texts, legal texts and extensive experience of regulatory affairs.

■職種未経験者：不可