Regulatory Affairs Manager

Requisition ID 2023-12797
# of Openings
Job Location(s)
Nakano-ku 13 Japan
Bachelor's Degree
Position Type
Full Time
Regulatory Affairs


  • 医療機器の承認、認証、届出に関する業務のマネージメント(Management on Regulatory Approval, Certification, Notification activities for Medical Devices)
  • 製造元を含む社内外の顧客に関する交渉とマネージメント(Management on and Negotiation with In-house and/or Outside customers including each Cook Manufactures)
  • 製造元および社内のおける薬事コンサルタント(RA Consultation for each division at Cook Japan and Cook Manufactures)
  • 人材育成(Human Resource Development)


  • 薬事申請におけるCook Japanと各製造所間の調整および管理(Coordinate and Manage timely Regulatory Submissions between Cook Japan and Cook Manufacturers.
  • 必要に応じ、申請書類(日英)の作成とレビュー(Personally write and review Regulatory Submissions (in Japanese or English) as needed.
  • Cook JapanおよびCook製造所における薬事的なスキルを改善するためのトレーニング資料の作成(Create training documents to improve regulatory skills in Cook Japan and at Cook manufacturers.)
  • Cook JapanおよびCook製造所のスタッフの薬事的なスキルを改善するためのトレーニング実施(Train employees to improve regulatory skills in Cook Japan and at Cook manufacturers.)
  • 薬事的要求事項を満たすための戦略および複数の選択肢を示すためCook製造所との協同(実現不可な障害ではなく、実施可能とするための解法)(Work with Cook manufacturers to provide strategy and multiple options for meeting regulatory requirements (provide “can do” solutions, not “cannot do” roadblocks).)
  • すべての申請における保険償還取得のサポート(Support reimbursement efforts for all submissions)
  • AMDDHBD、医機連等の業界活動におけるCook代表者(Represent Cook as a member of such industry organizations as AMDD, MTLF, HBD, JFMDA.)
  • 個々の薬事申請に対するCookグループのVisionを理解し、Cook Japanにおける信頼されるリーダーとなる(Learn the Cook Group vision for each regulatory submission and become an trusted leader in Cook Japan.)
  • COOK行動規範および企業法令順守要求事項を健全に理解し、適合する(Have a sound understanding of, and comply with, the COOK Code of Conduct and Company Compliance requirements.
  • 事業部の営業活動を最大化、薬事要求事項およびプロモーションコードを含む業界における要求事項への適合させるための協力者(Work as a collaborator for SBUs to maximize their activities and to comply with regulatory requirements and Industrial requirement including Promotional Code.)
  • GTW上での薬事書類および法令等の電子的データベース(電子書庫)の体系化(Organize electronic database (electronic library) of Regulatory Documents and government notifications on GTW (Global Technical Warehouse.))


  • 英語会話能力TOEIC700以上もしくは同等資格(English communication capability, TOEIC 700+ or equivalent.)
  • 外資系企業での勤務経験(Experience working for International companies)
  • 医療機器業界での薬事経験(Experience in regulatory for medical device industry)
  • PMDAとの交渉経験(Experience negotiating with PMDA)
  • 対人スキル(Interpersonal Skills)
  • 組織運営スキル(Organizational Skills)
  • マイクロソフトオフィスソフトへの熟練(Familiarity with Windows Office Software (Word, Excel, Power Point, Outlook Exchange)
  • チームプレイヤーとしてCook Japanの他の同僚との協同(One Cookとして)(Work with other colleagues of Cook Japan as a team player ( = One Cook))


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