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Regulatory Affairs QA Manager -Medical Device (Japan)

年収:800万 ~ 1000万

採用企業案件

役員面接

採用企業

グローバルレギュラトリーパートナーズ合同会社

  • 東京都

    • 会社規模非公開
  • 医薬品メーカー
部署・役職名 Regulatory Affairs QA Manager -Medical Device (Japan)
職種
業種
勤務地
仕事内容 Job Offer Summary:
Title: Job Offer Summary:
Title: pharmaceuticals Specialist
Department: Regulatory Affairs
Working Style: Hybrid
Area: Toronomon, Tokyo
Company Type: Foreign Multinational
Age Limit: No Age limit for applicants
Summary:
Regulatory Affairs Manager position as expert of registration for Medical Device with PMDA.

Responsibilities
Monitor and guide the organization to improve in compliance with the latest J-PMD Law and related ordinances / regulations required for Medical Device MAH (Manufacturing Authorization Holder).
Participate in and facilitate cross functional team for new product introduction to provide expertise in regulatory strategies.
Compile and register technical files for Medical Device
Research assesses and/or consults to identify on regulatory requirements to register new or changed products.
Assess and/or consult to identify GMP requirements to register new or changed products.
Develop strategies and plans to register and/or launch assigned product and execute by
coordinating internal and external stakeholders to complete its registration.
Administer communication with the regulators to support their review of our regulatory applications.
Monitor the progress of the preparation and review status by the local team outsource and regulator to update the international team and management at regular basis.
Lead and consult preparation execution of reimbursements application.
Monitor and assess regulatory impacts of new and revised regulations guidance and standard.
Review and approve new and revision of design manufacturing input from the manufacturers suppliers to ensure the compliance along with Japanese regulatory requirements.
Draft revise review consult and/or approve labelling to ensure the compliance to corporates requirement Japanese regulations.
Review and/or approve labelling to ensure they are documented and produced in compliance to domestic internal requirements on QMS
Register and maintain QMS Accreditation of pharmaceuticals.
Register and maintain MAH manufacturing Repairing Distribution and other licenses necessary for local distributor of the products.
Support QA team by providing regulatory insights to support creation and update of use/user’s manual PMS reporting and field actions.
Participate in maintenance and improvement of regulatory and development processes to support compliances.

労働条件 【勤務地】
Job Location : Japan , Tokyo

【雇用形態】
Job Type: Permanent Full-time (remote)
応募資格

【歓迎(WANT)】

【REQUIRED QUALIFICATIONS】
・3 years or more of experience in regulatory affairs for with PMDA.

Responsibilities
Monitor and guide the organization to improve in compliance with the latest J-PMD Law and related ordinances / regulations required for pharmaceuticals MAH (Manufacturing Authorization Holder).
Participate in and facilitate cross functional team for new product introduction to provide expertise in regulatory strategies.
Compile and register technical files for pharmaceuticalss
Research assesses and/or consults to identify on regulatory requirements to register new or changed products.
Assess and/or consult to identify GMP requirements to register new or changed products.
Develop strategies and plans to register and/or launch assigned product and execute by
coordinating internal and external stakeholders to complete its registration.
Administer communication with the regulators to support their review of our regulatory applications.
Monitor the progress of the preparation and review status by the local team outsource and regulator to update the international team and management at regular basis.
Lead and consult preparation execution of reimbursements application.
Monitor and assess regulatory impacts of new and revised regulations guidance and standard.
Review and approve new and revision of design manufacturing input from the manufacturers suppliers to ensure the compliance along with Japanese regulatory requirements.
Draft revise review consult and/or approve labelling to ensure the compliance to corporates requirement Japanese regulations.
Review and/or approve labelling to ensure they are documented and produced in compliance to domestic internal requirements on QMS
Register and maintain QMS Accreditation of pharmaceuticals.
Register and maintain MAH manufacturing Repairing Distribution and other licenses necessary for local distributor of the products.
Support QA team by providing regulatory insights to support creation and update of use/user’s manual PMS reporting and field actions.
Participate in maintenance and improvement of regulatory and development processes to support compliances.

EXPERIENCE
7 years or more of experience in regulatory affairs for pharmaceuticalss.
3 yrs. or more of experiences as one or more of representative of Medical Device MAH (Sokatsu Hinseki or Anseki Preferred.

SKILLS
Experience with communication with PMDA or notified body reviewers.
Good communication skills in English (written and oral)
Excellent Communication Skills- inter department communication necessary.
Sufficient PC skills to administer regulatory datasets and their revisions
Excellent team player Preferred.
Knowledge and experiences on pharmaceuticalss
Experience on pre submission consultation with PMDA
Experience to have participated in registration project with international stakeholders.
Facilitator
Good analytical and problem-solving skill
Self-motivator and self-learner Specialist
Department: Regulatory Affairs
Working Style: Hybrid
Area: Toronomon, Tokyo
Company Type: Foreign Multinational
Age Limit: No Age limit for applicants
Summary:
Regulatory Affairs Manager position as expert of registration for pharmaceuticalss with PMDA.

【GENERAL REQUIREMENTS】
・Minimum Experience Level: 3-year
・Career Level: Mid-Career
・Minimum English Level: Daily Conversation
・Minimum Japanese Level: Native
・Visa Status: Permission to work in Japan required

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更新日 2024/06/14
求人番号 3617125

採用企業情報

グローバルレギュラトリーパートナーズ合同会社
  • グローバルレギュラトリーパートナーズ合同会社
  • 東京都

    • 会社規模非公開
  • 医薬品メーカー
  • 会社概要

    【設立年月日】2016年10月25日
    【本社所在地】東京都港区虎ノ門5丁目13-1
               
    【事業内容】
    外資系医療機器および医薬品メーカー向け製造販売業務、コンサルティング業務

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