※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
[Position] RA Manager（薬事）／30代〜40代の方にお勧め
[Salary] 10〜13 million JPY ※Experiences and skills will be considered
RA Manager will be responsible for application for marketing approval of In-Vitro Diagnostic (IVD)/ Medical Device (MD), discussion and negotiation with PMDA, discussion and negotiation with MHLW, portfolio management for future In-Vitro Diagnostic/ Medical Device and maintain the related licenses for IVD/MD under the supervision of RA senior manager.
- Responsible for basic discussion and negotiation with PMDA and MHLW for product approvals of IVD/MD.
- Effective escalation and discussion with headquarters RAQA and R&D team (mainly in the US and EU) on regulatory submissions including quality and safety issues to keep the approvals.
- Responsible for cross functional discussion and escalation management and close collaboration with Internal Stakeholders such as business teams, medical affairs, technical support team and internal RAQA team (clinical affairs and QA) as a supportive business partner.
- Work closely with marketing and product management within Japan and global to effectively manage the product portfolio for current and future products of Life Technologies Japan.
- Work with QA to get and maintain the licenses such as MAH (Marketing Authorization Holder) for IVD/MD.
- Pharmacist license (Preferred)
- Fluent in Japanese and business level in English (oral and written)
- Team player with internal/cross-functional team
- Must have an experience of Regulatory Affairs for IVD/MD for a minimum of 5 years.
- Experiences of consultation, discussion, and negotiation with PMDA through consultation, application for marketing approval and partial change approval.
- Experiences of reimbursement process for clinical test (preferred), negotiation with MHLW.
- Solid knowledge of Pharmaceuticals & Medical Devises Act., QMS ministerial ordinance.
- Experiences of QMS operations
- Experiences of Regulatory Affairs for veterinary IVD/MD
Please click "apply" if you are interested in the job.
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Further details about the company and position will be notified at a later date.
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Science