- Tokyo, Japan
Site Name: Japan - Tokyo - Akasaka
Posted Date: Apr 23 2020
Job Purpose & Key Responsibilities
- Develop and implement Japan regulatory strategy for the oncology projects in Japan, aligned with global regulatory strategy.
- Lead oncology group and be role model for the staffs.
- Serve as the primary interface to global regulatory affairs.
- Take responsibility as the primary interface for health authority (PMDA/MHLW) activities such as consultation meeting, other negotiation based on regulatory science.
- Take responsibility for leading the preparation of submissions, which include CTNs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc.
- Represent Regulatory Affairs in various cross-functional teams, including Project Teams, JNDA Submission Teams, etc.
- Encourage to secure/update knowledge regarding innovative development in oncology based on regulatory science, considering regional competitive landscape, regulatory environment
- Report to head of New Drug RA Dept, Regulatory Affairs
Required Skill, Experience, Etc
- Thorough knowledge of global regulatory guidance related to the overall global regulatory strategy.
- Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
- Must be able to be innovative in way of thinking, analyzing and solving problems with minimal supervision and attention to detail.
- Ability to attract talent, challenge and manage and develop direct reports
- Experience for more than 10 years in drug development, including experience for more than 5 years in regulatory area to work in global circumstance.
- Experience in oncology drug's regulatory submissions and approvals.
- Thorough knowledge of the drug development process in Japan, CTN, PMDA consultation and NDA.
- Bachelor's degree in scientific discipline
- Excellent communication skill in English to be able to make a deep discussion in regulatory strategy with global relevant members.
- Experience in multiple phases of oncology development
- Manage performance for direct reports
- Assist in managing the Workforce plan and resource demands (including above project work and staff recruitment)
- Master's degree or higher in scientific discipline, advanced scientific degree
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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