■ 職務内容 / Job Description Medical Communication Scientist (MCS) is a role name in AZKK and is generally known as medical writer. MCS is responsible for the authoring of clinical-regulatory documents and submission packages that communicate the evidence
Title: Regulatory Affairs Manager Company: IPSEN K.K. Job Description: Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
The RA manager will comply with the Pharmaceutical Affairs Law and related enforcement regulations, enforcement ordinances, ministerial ordinances, notifications, etc., carry out RA duties in cooperate with the Quality Assurance Department and the Clinical Research Department,
Job Purpose & Key Responsibilities As a Japan Submission manager, you will work not only with Japan submission teams but also with Global Submission Managers closely and as needed with Global Publishers and Global Submission teams to manage complex regulatory submissions (including
Work Flexibility: Hybrid or Onsite The Jobs Mission 弊社は、日本で最初に単回使用医療機器の再製造事業を開始したマーケットリーダーです。新製品の承認取得や償還価格設定などの薬事業務やその他関連業務を通じて、再製造単回使用医療機器（R-SUD）の正しい理解を促進し、日本におけるR-SUDの迅速な普及に貢献することを期待します。 Key Activities & Accountabilities 当社が製造販売する再製造単回使用医療機器に関する薬事業務を行っていただきます。 製造販売承認の取得 海外製造元に日本の要求事項をインプットし、協力して申請方針を立案 PMDA対面助言 試験の計画作成 資料収集及び申請書作成 照会対応など 承認の維持管理業務 変更管理 QMS定期更新 QMS適合性調査申請 海外製造元に日本の要求事項をインプットする 調査申請に必要な資料を収集、調査申請書作成・提出、照会対応 原則実地調査のため、必要に応じて海外製造所、製造販売業者及び国内製造所の調査をサポート 保険収載業務 新規に保険償還を取得する製品の保険適用希望書を関連部署と協働で作成 厚生労働省との折衝 ヒアリングや中医協への対応 その他 販促物のレビュー また、社外・社内関係者とのコミュニケーションを通して、R-SUDの普及を目指していただきます。 厚生労働省やPMDAと協働し、R-SUDを正しく、かつ迅速に普及するための活動を行う。 海外及び国内のストライカーメンバーと良好な協力関係を築き、R-SUDの日本市場への導入を促進する。
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
Job Title Regulatory Affairs Senior Manager - IGTD Job 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
Job Title Regulatory Affairs Manager Job 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. Develop local regulatory strategy and lead the strategic
Job Title Regulatory Affairs Senior Manager Job 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
Lead regulatory submission process, to contribute expansion of business. Maintain of product registration and related lincenses like MAH or manufacturing site through change control process. Requires basic knowledge of IVD/MD regulation and QMS. Will also cover regulations about
Description Kenvue is currently recruiting for: Legal Entity Controller Job Description: The Legal Entity Controller role primarily oversees the legal entity (LE) financial close process , financial reporting process, ensuring the integrity and precision of the
Description Who We Are At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, were the house of iconic brands - including Dr.Ci:Labo®, NEUTROGENA®, AVEENO®,
Job Description Summary -Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change
Job Description Summary Demand Planner will be the core of maintaining stable supply of Sandoz products to our Japanese customers and patients as well as maintain company’s healthy financial performance. This role drives Demand and Supply
JOB SUMMARY: JCL is a member of Japan Compound Team (JCoT) and leads Clinical Team (CT) when assigned. • JCL is responsible for development and execution of clinical development strategy for target indication in assigned compound
Job Description Summary Defines and drives scientifically sound and business driven project strategy. Reviews, manages, proactively challenges, and controls status of projects operations of the programs and budgets; manages schedules and may prepares status reports. Guides
Be part of a top 10 Global CRO thats entering the Japan market as a first member. Lead in RA activities to submit clinical trial documents to obtain approval. Client Details * Top 10 global CRO
