Director, Japan CMC

2ヶ月前

Osaka Takeda Full time￥800,000 - ￥2,400,000 per year

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use.  I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

As a leader of Japan CMC & Devices RA New Drug Application group, lead the group to fulfill expected roles and responsibilities according to Global RA vision/mission and Company's vision/mission/value.

  • Oversee the development and execution of regulatory CMC development and registration strategies of all assigned products throughout clinical development and NDA approval.
  • Successfully communicate and negotiate with Health Authorities as necessary, directly and indirectly, especially when difficult discussions are anticipated.
  • Develop constructive relationships with and proactively escalate potentially critical issues to key internal and external stakeholders, including Alliance Partners.
  • Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines and provide guidance to direct reports and all group members for their training and developments.
  • Lead a group of individuals to support group's goals according to agreed timelines, standards and business priorities

日本開発センター CMC薬事部/Takeda Development Center Japan, Japan CMC & Devices Regulatory Affairs

医療用医薬品の薬事関連業務のうちの品質パート(CMC関連)について、開発初期段階から申請・承認、市販後のライフサイクルを通じて責任を持つ部門です。

職務内容

日本における医薬品(化学合成品、バイオ医薬品)の新規申請及び承認取得後のCMC薬事に関連する下記業務に責任を持つグループの責任者

  • 申請戦略・申請計画のCMCパートについて立案・遂行
  • 薬事関連の当局相談に係る戦略策定及び遂行
  • 製造販売承認申請業務(CMCパート)
  • 導入案件のCMC薬事関連の評価
  • グループメンバーの教育訓練及び人財育成

応募要件

<学歴>

4年制大学(理系学部)卒業以上(修士以上であることが望ましい)

<実務経験>

以下の業務の知識経験が10年程度以上

  • 化学合成品、バイオ医薬品及びコンビネーション医薬品の医薬品の研究開発、製造、試験に関わる知識経験
  • 医薬品開発及び承認申請業務及び市販後の変更管理に基づく薬事手続きの知識経験
  • 日本の規制当局との面談及び相談の実務経験
  • 国内外のステークホルダーとの良好な関係構築及びコミュニケーション
  • 組織運営/人材マネジメントの実務経験(5年以上の経験を持つことが望ましい)

<スキル・資格>

  • 医療用医薬品に関する規制要件・ガイダンス(ICH、薬機法、欧米の要件、等)に関する知識
  • GMP(治験薬含む)に関わる業務経験を有することが望ましい

<語学>

ビジネスレベルの十分な日本語及び英語でのコミュニケーション能力(TOEIC 750点以上等)

<その他>

勤務地は大阪又は東京で、会社オフィスで5回/月以上の勤務が必要

求める人物像

1)新薬開発業務に熱意を持って取り組むことができる人間性

2)実務経験に裏打ちされた専門性

3)社内外の人間をまとめていけるリーダーシップ

4)規制当局や社内外Stakeholderとの交渉力

5) グローバル組織の一員として活躍する国際感覚

6)新しいことにチャレンジできる気概

7) 読み手に合わせた適切な文書作成力(日本語・英語)

仕事のやりがい

当社が全世界で開発又は販売している医療用医薬品(希少疾患領域を含む)を日本国内の患者様に届けることに貢献できる。

本職務で身につくスキル・経験

国内での医薬品開発の開発初期段階から製造販売承認申請・承認取得、市販後のライフサイクルを通じてCMC関連業務の戦略立案、遂行、当局相談、などの薬事関連業務の網羅的な知識と経験が身につく。

海外の開発部門/製造所などと密に連携して日本国内における薬事申請業務を実施するスキル・経験が身につく。

Takeda Compensation and Benefits Summary:

  • Allowances: Commutation, Housing, Overtime Work etc.

  • Salary Increase: Annually, Bonus Payment: Twice a year

  • Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45

  • Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)

  • Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.

  • Flexible Work Styles: Flextime, Telework

  • Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.

Important Notice concerning working conditions:

  • It is possible the job scope may change at the company's discretion.

  • It is possible the department and workplace may change at the company's discretion.

Locations

Osaka, JapanTokyo, Japan

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

  • Director, Japan CMC

    2ヶ月前

    Osaka Takeda Full time￥800,000 - ￥2,400,000 per year

    As a leader of Japan CMC & Devices RA New Drug Application group, lead the group to fulfill expected roles and responsibilities according to Global RA vision/mission and Company's vision/mission/value. · 日本開発センター CMC薬事部/Takeda Development Center Japan, Japan CMC & Devices Regulat ...

  • Director, Japan CMC

    3日前

    Osaka, Osaka Takeda ￥1,200,000 - ￥1,800,000 per year

    Job summary · As a leader of Japan CMC & Devices RA New Drug Application group, lead the group to fulfill expected roles and responsibilities according to Global RA vision/mission and Company's vision/mission/value. · ...

  • SE/BrSE Java

    2週間前

    Osaka, Osaka CMC Global Careers ￥4,500,000 - ￥7,800,000 per year

    We are seeking a Java developer to work closely with Japanese clients to analyze and clarify requirements. · Perform full development cycle: Basic Design BD Detailed Design DD Development TestingWork closely with Japanese clients. · ...

  • 料飲部長

    2ヶ月前

    Greater Osaka Area Hyatt Regency ￥900,000 - ￥1,200,000 per year

    Located on Osaka Bay, Hyatt Regency Osaka is in close proximity to popular attractions such as the ' Kaiyukan ' aquarium and Universal Studios Japan. · As the Director of F&B, you will fill a vital role by directing and supervising F&B Service preparation for all Outlets and Even ...

  • Freelance Tour Director

    3週間前

    Osaka, Osaka EF ￥300,000 - ￥500,000 per year

    We are looking for people with a deep love for Japan and a passion for sharing it with young travellers from North America. Whether your expertise lies in history, pop culture, fashion, food, sports, or beyond, you'll inspire students to learn more about the world around them. · ...

  • Vice President, Regulatory Affairs Japan

    2週間前

    Osaka, Osaka Takeda ￥10,000,000 - ￥20,000,000 per year

    The Vice President, Regulatory Affairs Japan will contribute to the vision and goals of Global Regulatory Affairs (GRA) and ensure that Global Regulatory Affairs (GRA-J) Japan objectives are aligned with those. The role will provide leadership, strategic direction, and managerial ...

  • Director of rooms/宿泊部長

    1ヶ月前

    Greater Osaka Area Hyatt Regency ￥400,000 - ￥800,000 per year

    A Director of Rooms is responsible for ensuring the smooth operation of guest services, concierge services, housekeeping and communications in an attentive, friendly, efficient, and courteous manner. · The Director of Rooms is also overall responsible for providing all guests wit ...

  • Director, Market Access

    1ヶ月前

    Osaka, Osaka Intuitive ￥6,000,000 - ￥12,000,000 per year

    The Director of Market Access and Custom Analytics (MACA) for Japan will develop and execute applied health economic patient access strategies and tactical, evidence-based change management plans to support the Commercial Sales organization. · Work collaboratively with various In ...

  • 医薬品品質保証チーム スペシャリスト

    3日前

    大阪市, 日本, Santen ￥1,800,000 - ￥2,200,000 per year

    Job summary · Santenの医薬品品質保証チーム スペシャリストの職務は、参天製薬が日本国内で製造販売する医療用/一般用医薬品・健康補助食品の品質保証体制を維持および管理し、海外輸出入品を扱う本社品質保証機能(グローバル機能)を担います。 · ...

  • Director, Market Access

    13時間前

    Osaka, Japan Intuitive $120,000 - $180,000 per year

    The Director of Market Access and Custom Analytics will develop and execute applied health economic patient access strategies to support the Commercial Sales organization. The role will work with hospitals in Japan to demonstrate the value of Intuitive technology by developing re ...

  • 医薬品品質保証チーム スペシャリスト

    2週間前

    Osaka Santen Full time￥900,000 - ￥1,200,000 per year

    Santenは、眼科医療に特化した130年の歴史を持つ製薬企業です。日本発のグローバル企業として60カ国以上に拠点を持ち、目の健康のために様々な革新的な治療法とデジタルソリューションを提供し、世界中の人々の視覚に関わる社会問題に取り組んでいます。 · ・Santen品質マニュアル、cGXPおよび国内外規制に従い社内工場およびGXP組織と連携し、日本市場における主導役として品質システムの構築と維持管理および強固なプロセスの構築・標準化に向けた改善を行う · ・製造委託先、供給業者管理の運用および継続的な改善を行う · ・日本・海外規制及び標的市場国規制に適 ...

  • 医薬品品質保証チーム スペシャリスト

    2日前

    大阪市, 日本, Santen ￥50,000 - ￥200,000 per year

    Santen品質マニュアル、cGXPおよび国内外規制に従い社内工場およびGXP組織と連携し、日本市場における主導役として品質システムの構築と維持管理および強固なプロセスの構築・標準化に向けた改善を行う。 · ...

  • Associate Director, Business Development

    3日前

    Osaka, Osaka Agoda ￥1,200,000 - ￥3,000,000 per year

    The Associate Director for Japan will develop and deploy Agoda's Japan strategy, provide guidance and leadership to ensure the successful account management of Agoda's major partners, and deliver on targets and growth expectations. · Develop and implement strategies to accelerate ...

  • Director, Brand Marketing

    1ヶ月前

    Osaka Universal Studios Japan(USJ LLC) ￥5,000,000 - ￥10,000,000 per year

    In charge of developing annual plans to drive domestic attendance by utilizing major attraction launches and seasonal events. Develops marketing communication contents and activation plan contents by working with advertising agencies. Contributes to enhance USJ brand equity throu ...

  • People and Culture Manager

    13時間前

    Osaka Four Seasons ￥900,000 - ￥1,200,000 per year

    We are seeking a passionate and strategic People & Culture Manager to lead the development and execution of people strategies that foster a positive workplace culture, drive employee engagement, and support organizational growth. ...

  • Sales Manager, Off-trade West Japan

    2日前

    Osaka Inspire Consulting Limited ￥5,500,000 - ￥11,000,000 per year

    The successful candidate will manage and grow the retail business in Western Japan, collaborating with distribution partners and key retail clients to execute the group's strategy and expand the Off-trade channel. · Develop and execute regional Off-trade strategies, including bot ...

  • Conrad Osaka

    2ヶ月前

    Osaka, Osaka Hilton ￥900,000 - ￥1,200,000 per year

    The Sales Manager assists the Director of Sales in leading and supervising the Sales Team. He / she oversees and directs all aspects of the negotiation and coordination process as well as the successful handling of Corporate / FIT / M.I.C.E. / Social / Tour & Travel events as ass ...

  • Regional Director of Finance

    1ヶ月前

    Osaka Four Seasons Hotels and Resorts Full time￥6,000,000 - ￥12,000,000 per year

    The Regional Director of Finance forms part of the Hotel Leadership team who collectively make key strategic and operational decisions for the Hotel or Resort. The Director is responsible for safeguarding the hotel assets and financial resources contributing towards maximizing ho ...

  • Executive Secretary

    1ヶ月前

    Osaka, Osaka JAPAN Immigration Lawyer YUGE OFFICE ￥3,500,000 - ￥4,500,000 per year

    We are seeking our first hire in Japan – an Executive Secretary – who will play a key role in supporting the Representative Director and overall company operations. This role offers a unique opportunity to be part of an international financial organization from its early stage of ...

  • Enterprise Regional Director

    1ヶ月前

    Osaka, Osaka NetApp ￥600,000 - ￥1,200,000 per year

    This is an experienced and results-driven Head of Enterprise role to lead sales efforts in WEST, Japan. This role will be responsible for driving sales growth, managing a team of sales representatives, and building strong relationships with key clients in WEST, Japan. · Market De ...

  • General Manager

    13時間前

    Osaka, JP CIC ￥1,200,000 - ￥2,400,000 per year

    CIC & LSIC is looking for a highly skilled and independent individual to take on the role of General Manager at our new Japanese campus in Osaka. As General Manager, you will balance being the external face of CIC &LSIC with your responsibility for all of the day-to-day workings ...