RA Manager(薬事) - 科学機器・試薬メーカー

勤務地 東京都
雇用形態 正社員
給与 ¥10000000.00 - ¥13000000.00 per annum
専門 ライフサイエンス(医療機器・製薬・化学・ヘルスケア・農業・畜産),
職種 薬事,
お問合せ Ryosuke Watanuki
JOB ID JO-2108-462857

※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.

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[Position] RA Manager(薬事)/30代〜40代の方にお勧め
[Location] 東京都/在宅勤務制度あり
[Salary] 10〜13 million JPY ※Experiences and skills will be considered
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[Company Description]
外資系科学機器・試薬メーカー

  • 分析機器、医療機器、ラボ用機器、バイオ関連機器、研究用試薬などを手掛けています

[Responsibilities]
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.

[Requirements]

  • 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


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#LI-REMOTE
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Science