Job summary
Job category | Technical (Sales / Design / Development / Production Control)/Development / Research / Experimentation / Project Manager |
---|---|
Industry | Health Care/ Other Health Care |
Employment type | Uncategorized |
Position level | Other |
Number of openings | 1 |
Desired entry time | - |
Required language skill |
English (Fluent) |
Foreign language competence | - |
Working hours | Others |
Welfares / Leave systems | |
Assistance in visa application | - |
Number of foreign employees | - |
Work details
Company Overview
血液がん・免疫に強み/高年収/ランキング15位以内
Job Description
- Work with submission team in Japan and Global to implement Japan regulatory strategy plans for both investigational and marketed products
- Participate in or lead Japan submission team and relating sub-team (project team) for assigned product(s) / project(s)
- Create, lead and review major regulatory applications (eg. CTNs, Briefing Documents for PMDA consultation, Orphan Drug Applications, Marketing Approval Applications, etc.)
- Participate in and/or lead regulatory interactions with MHLW/PMDA on assigned projects.
- Participate or acts as regulatory representative on various cross-functional teams
- Participate in cross-functional initiatives
- Maintain and reinforces compliance with Company SOPs and Work practices
- Provide input and comments on draft regulatory guidance
Requirements
- Bachelors degree in scientific discipline; Advanced scientific degree preferred.
- More than 10 years pharmaceutical industry experience.
- Thorough knowledge of the Japanese drug development process, CTN, PMDA consultation, NDA and NHI pricing process.
- Demonstrated experience in preparing Japan submissions.
- Good Understanding of the drug development process.
- Specific expert knowledge in one or more key areas expected: Oncology or Regenerative Products Development / CMC / PK / Clinical / Promotional
- Interdependent partnering skills, team-orientated with the ability to influence outcomes are necessary skills in the environment.
- Communication skill in English
- Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
- Must be able to innovate, analyze and solve problems with minimal supervision and maximum attention to detail
- Domestic and occasional International travel may be necessary
About interview
Liaison
Sr Manager, Regulatory Affairs(CAR-T)
RGF HR Agent
1400 〜 1600 ten thousand JPY