Global Biopharmaceutical Company focused in Oncology with products to market and a strong and exciting development pipeline. The company is focused on Oncology. They have a strong and stable backing and are well-regarded in the industry for their work.
Seeking a Senior Regulatory Affairs Manager to join the team. This person will have work with the Japan team and Global to implement Japan Regulatory strategy plans for both investigational and marketed products
The Senior Regulatory Affairs Manager will be in an integral member of the Regulatory Affairs team and will be involved in strategic development for the team. The individual will lead and participate in the Japan submissions team and relevant projects and sub-teams.
- Work with submission team in Japan and Global to implement Japan regulatory strategy plans for products 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
<Rewards & Benefits>
- Competitive salary package
- Global mobility opportunities
- International and collaborative team environment
- Opportunities for career progression
- Bachelor's degree in scientific discipline
- More than 10 years pharmaceutical industry experience, including more than 5 years in regulatory affairs 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.
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