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【CSH】REGULATORY AFFAIRS SR.SPECIALIST OR SPECIALIST

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Regulatory Affairs
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190002CQ Requisition #
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Job Title: Regulatory AFFAIRS   SR.Specialist or Specialist

Department:Cardiovascular Coronary/SH Regulatory Affairs

Reporting to:CV Coro/SH RA Manager



Main Mission of Job

“Careers that Change Lives”

海外製造元及び社内他部門と協力し、新規製品の国内導入に向け薬事承認をタイムリーに取得する。

業界トップレベルの医療機器製造販売業者として、コンプライアンスの維持管理に努める。


Main Responsibilities

A Day in the Life

·      品目薬事申請業務の進行(海外製造元とのコレポン、申請書作成、審査機関との応答を含む)

·      添付文書作成並びに維持管理

·      保険適用希望申請業務

·      製品の変更情報に対する評価

·      製品登録業務

·      販促物(カタログ等)の内容確認

·      業界活動

·      その他 薬事関連業務の進行


Must Haves (Minimum Requirements) 

Knowledge/Education

-大学卒業以上

―TOEIC 700点相当以上(英語でのコミュニケーションに不自由のないこと)

 

Job Experience

-薬事業務経験3年以上(Specialistの場合)-薬事業務経験5年以上(Sr.Specialistの場合)

 

Skills/Competency Required

-薬機法、関連法規等に関する基本的な理解

-的確な文章表現能力(日本語・英語)

-マルチタスク遂行能力、調整力

-プロジェクトマネジメント能力

-論理的思考力

ー海外カウンターパートとの業務遂行経験

 

Computer Skills

-Word/Excel /PowerPoint

 

Physical Requirements

- 宿泊を伴う海外出張が可能なこと

 

Nice to Have

自然科学系理系専攻


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Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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