Regulatory Affairs Specialist

で見つかりました。 Talent JP C2 - 4日前

Tokyo Philips Full time

Job Title

Regulatory Affairs Specialist

Job Description

職務説明

Exciting opportunity to support introducing new product/solution, maintain regulatory compliance and actively participate transformation/improvement activities.

新製品やソリューションの導入をサポートし、規制コンプライアンスを維持し、フィリップスの変革/改善活動に積極的に参加する業務です。

  • Communicate with Global RA partners to gather/confirm necessary information.
  • Author product submission/notification document, QMS/FMR document and reimbursement document.
  • Update regulatory database with necessary record/information.
  • Proceed promotional material review.
  • Participate and proceed various transformation/improvement activities as a team member.

​・グローバルRAパートナーと協力し、必要な情報を収集・確認
・製品申請/届出文書、QMS/FMR文書、償還文書のオーサリング
・薬事データベースの更新
・プロモーション資料のレビュー
・チームメンバーとして様々な変革/改善活動に参加、推進

ベストマッチングする要件

  • Self-motivated and able to prioritize to handle multiple tasks/responsibilities.
  • Bachelor of Science Degree (Master preferred)
  • Fluent in Japanese and English

・自発的で、複数の仕事/責任を処理するために優先順位をつける

・理学士号(修士号取得者歓迎)

・日本語および英語に堪能であること

基本月額及び諸手当

博士 440,000円 (基本給 352,000円+30時間分の固定残業代 88,000円)

修士 386,800円 (基本給 309,400円+30時間分の固定残業代 77,400円)

学士 350,000円 (基本給 280,000円+30時間分の固定残業代 70,000円)

準学士 325,000円 (基本給 260,000円+30時間分の固定残業代 65,000円)

通勤手当:月150,000円まで支給
※通勤手当の場合新幹線・飛行機通勤は不可
※固定残業時間を超える時間外労働、休日労働および深夜労働に対しては割増賃金を支給
※賞与:年1回

※昇給給与改定:年1回

試用期間

6カ月(待遇の変更なし)

休日休暇

土日、祝日、年末年始(12/29~1/4)
年次有給休暇20日+Care leave10日+Sick leave30日
※6年目以降年次有給休暇が25日となる
特別休暇(結婚・出産・育児・慶弔・ボランティア・リフレッシュ)

待遇・福利厚生・社内制度

完全フレックスタイム制度あり(コアタイムなし)、各種社会保険、総合福祉団体定期保険、長期障害所得補償保険、人間ドック、確定拠出年金制度、退職金制度、自社製品の社員割引制度、カフェテリアプラン(年間72,000ポイント)、年齢にかかわらず婦人科検診選択可能(女性社員対象)、社内マッサージルーム(本社)など

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

• Learn more about our business.

• Discover our rich and exciting history.

• Learn more about our purpose.

If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

  • Regulatory Affairs Specialist

    で見つかりました。 Talent JP C2 - 4日前

    Tokyo Medtronic

    JOB TITLE: 薬事スペシャリスト · DEPARTMENT: 品質保証・薬事 薬事 Cardiovascular/DIB ポートフォリオ · REPORTING TO:MANAGER · ********************************************************************************************** · Main Mission of Job · "Being a "bridge" to deliver "meaningful" medical device t ...

  • Senior Regulatory Affairs Specialist

    で見つかりました。 Talent JP C2 - 3日前

    Tokyo Medtronic

    JOB TITLE: シニア薬事スペシャリスト DEPARTMENT: 薬事 Medical Surgical ポートフォリオ REPORTING TO: Surgical Robotics 薬事マネージャー ********************************************************************************************** · Main Mission of Job · Surgical Roboticsチームは、手術用ロボット及びその附属品を取り扱っています。患者様に最先端の ...

  • 東京/CMC Regulatory Affairs Specialist】英語を活かせる環境

    で見つかりました。 beBee S2 JP - 5日前

    東京都, イーピーエス(株)

    医薬品の製造と品質管理に関する分野の薬事業務を担当いただきます。 · 医薬品の製造方法と品質試験方法に関する資料作成の経験を豊富に得ることが出来ます。 · ・マスターファイル(MF)の作成・登録と、登録後の変更対応 · ・外国製造業者認定取得・更新と認定期間中の変更対応 · ・GMP適合性調査のサポート業務 · ・CTD Module 2.3及び承認申請書の作成 · ・PMDA相談資料の作成及び相談の実施 · ・薬事規制の情報収集及び海外顧客への説明 ...

  • Senior Regulatory Affairs Specialist

    で見つかりました。 beBee S2 JP - 3日前

    Tokyo Fortive Full time

    Position Summary · The Senior Regulatory Affairs Specialist (Sr, RA Specialist) is responsible for developing regulatory strategies, preparing Local submissions and supporting international submissions to obtain and maintain approval/certification for drug/device products and the ...

  • Regulatory Affairs

    で見つかりました。 beBee S2 JP - 2日前

    Tokyo Cornerstone Recruitment Japan

    【COMPANY OVERVIEW】 · An American mega device company with more than 50 years of history of establishment. · 【JOB RESPONSIBILITIES】 · Support QMS conformity survey application. · In charge of class I to III medical device application. · Support other teams. · 【WHY YOU SHOULD APPLY ...

  • Regulatory Affairs Manager

    で見つかりました。 Talent JP C2 - 5日前

    Tokyo Philips Full time

    Job Title · Regulatory Affairs ManagerJob Description · Job title: · Regulatory Affairs Manager · Your role: · Exciting opportunity to play an integral role in introducing new product/solution, maintain regulatory compliance and leading transformation/improvement activities. · De ...

  • Regulatory Affairs Manager

    で見つかりました。 Talent JP C2 - 3日前

    Tokyo Galderma Full time

    With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans th ...

  • Regulatory Affairs Manager

    で見つかりました。 Talent JP C2 - 6日前

    Tokyo Philips Full time

    Job Title · Regulatory Affairs Manager (SRC)Job Description · Job title: · Regulatory Affairs Manager · Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innova ...

  • Regulatory Affairs Manager

    で見つかりました。 beBee S2 JP - 5日前

    Tokyo Philips Full time

    Job Title · Regulatory Affairs ManagerJob Description · Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. ...

  • Regulatory Affairs Senior Manager

    で見つかりました。 Talent JP C2 - 5日前

    Tokyo Philips Full time

    Job Title · Regulatory Affairs Senior Manager - IGTDJob Description · Regulatory Affairs Senior Manager · Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through inno ...

  • Senior Regulatory Affairs Specialist

    で見つかりました。 Talent JP C2 - 4日前

    Koto City Advanced Sterilization Products Full time

    responsibilities · . §Related Regulatory and/or Quality Assurance experience. · Nice to Have: · 5+ years medical device industry experience. · Advanced degree in a scientific discipline (engineering, physical/biological or health sciences). · New product development experience ...

  • Regulatory Affairs Senior Manager

    で見つかりました。 beBee S2 JP - 5日前

    Tokyo Philips Full time

    Job Title · Regulatory Affairs Senior ManagerJob Description · Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better to ...

  • Regulatory Affairs Senior Manager

    で見つかりました。 Talent JP C2 - 5日前

    Tokyo Philips Full time

    Job Title · Regulatory Affairs ManagerJob Description · Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. ...

  • Industrial Chemical Regulatory Affairs

    で見つかりました。 Talent JP C2 - 5日前

    Tokyo Cargill

    Job Purpose and Impact · The Industrial Chemical Regulatory Specialist II will ensure compliance with government chemical regulations or standards in the areas of product compliance, hazard communication, customer documentation and other regulatory functions. In this role, you w ...

  • Director, Regulatory Affairs, Japan

    で見つかりました。 Talent JP C2 - 6日前

    Chiyoda Jazz Pharmaceuticals Full time

    The job holder manages specified aspects of regulatory work at JAZZ. The Director Regulatory Affairs Japan is responsible for providing input into Japan strategy and ensure the Global Core Team's strategy and submission components meets the Japanese Health Authority requirements ...

  • 2025年新卒】Regulatory Affairs Specialist

    で見つかりました。 beBee S2 JP - 5日前

    Tokyo Philips Full time

    Job Title · 【2025年新卒】Regulatory Affairs SpecialistJob Description · 職務説明 · Exciting opportunity to support introducing new product/solution, maintain regulatory compliance and actively participate transformation/improvement activities. · 新製品やソリューションの導入をサポートし、規制コンプライアンスを維持し、フィリップス ...

  • Japan Regulatory Affairs Operations Manager

    で見つかりました。 Talent JP C2 - 3日前

    Tokyo Biogen Full time

    Job Description · Responsible for all activities of Japan regulatory operations as a lead of regulatory operation in collaboration with Global RA, Japan R&D, and other functional areas within Biogen. · Manage and maintain regulatory operational activities in drug development, ND ...

  • Regulatory Affairs Manager, Head Pharmacist

    で見つかりました。 Talent JP C2 - 4日前

    Tokyo Guerbet Long-term/regular

    Description · 1. General Marketing Compliance Officer (SOKATSU-SEKININSHA) Responsible to assure compliance with GVP and GQP through supervision and instruction to safety manager and quality assurance manager. Must report issues and risks to the MAH. Name and address are registe ...

  • Senior Manager, Regulatory Affairs, Japan

    で見つかりました。 Talent JP C2 - 4日前

    Chiyoda Jazz Pharmaceuticals Full time

    JOB PURPOSE · The Manger, Regulatory Affairs, Japan shall manage regulatory activities assigned in GW Pharma order to obtain new drug application(NDA) approval, partial change application(PCA) approval, to submit appropriate minor change notification(MCN) and to execute other ne ...

  • Senior Regulatory Affairs Manager

    で見つかりました。 beBee S2 JP - 5日前

    Matsudo-shi Abbott Laboratories OTHER

    Abbott Rapid Diagnostics is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other co ...