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