薬事アソシエイトマネージャー - 医療機器メーカー

勤務地 東京都
雇用形態 正社員
給与 ¥9000000.00 - ¥10000000.00 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 Taro Satake
JOB ID JO-2111-464991

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

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[Position] 薬事アソシエイトマネージャー
[Location] 東京都/在宅勤務制度あり
[Salary] 9〜10 million JPY ※Experiences and skills will be considered
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[Company Description]
外資系医療機器メーカー

  • 人工関節や手術支援ロボット、再生医療製品を手掛けています

  • 整形外科領域のリーディングカンパニーでマーケットシェアは世界トップクラス

[Responsibilities]
This position is responsible for managing all facets of regulatory and market access support to Spine businesses. In addition to managing projects and leading a RA team of market access professionals, this position involves interaction with government authorities and hands on work in dealing with product submissions. In order to achieve Company objectives, a comprehensive understanding of products and their use, as well as an understanding of regulations and their application is required.

Overall management of Spine product segments projects, including working closely with regional RA & Global manufacturing sites to drive reduction of registration cycle time through Speed to Market initiatives.

Define and implement Japan regulatory & reimbursement strategies and plans

  • Manage and track Speed to Market performance for Japan

  • Update registration cycle time metrics on a quarterly basis

  • Update comprehensive commentary report on a yearly basis

Create application documents (new/supplement/ninsho) and follow process through to approval

  • Partner with CRO for regulatory clinical studies

  • Partner with QA/QC to create and review labeling

  • Partner with Commercial to create C1 Reimbursement application

  • Provide guidance and consultation for regulations

[Requirements]

  • Bachelor's Degree in Life Sciences, technical (engineering) or related field; advanced degree in engineering advantageous.

  • 10 years experience in medical industry, with a minimum of 5 years experience in a Regulatory Affairs role.

  • 3 - 5 years people management experience.

  • Experience in electrical equipment and combination products regulations is strongly preferred.

  • A combination of education and experience may be considered.

  • Superior people management and leadership skills

  • Highly motivated and strong project management skills

  • Strong strategic mindset and hands on approach

  • Excellent communication and interpersonal skills

  • Responsible, professional, detail oriented and patient

  • Proficient in reading, writing and speaking English (TOEIC 600+)

  • Occasional domestic and international business trips


Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Reference: JO-2111-464991
#LI-REMOTE
Seniority Level: Mid-Senior level
Job Function: Health Care Provider