東京】体外診断用医薬品・医療機器の薬事申請(国内担当) - 東京都 港区 赤坂
3週間前

仕事の説明
, consectetur adipiscing elit. Nullam tempor vestibulum ex, eget consequat quam pellentesque vel. Etiam congue sed elit nec elementum. Morbi diam metus, rutrum id eleifend ac, porta in lectus. Sed scelerisque a augue et ornare.
Donec lacinia nisi nec odio ultricies imperdiet.
Morbi a dolor dignissim, tristique enim et, semper lacus. Morbi laoreet sollicitudin justo eget eleifend. Donec felis augue, accumsan in dapibus a, mattis sed ligula.
Vestibulum at aliquet erat. Curabitur rhoncus urna vitae quam suscipit
, at pulvinar turpis lacinia. Mauris magna sem, dignissim finibus fermentum ac, placerat at ex. Pellentesque aliquet, lorem pulvinar mollis ornare, orci turpis fermentum urna, non ullamcorper ligula enim a ante. Duis dolor est, consectetur ut sapien lacinia, tempor condimentum purus.
すべての上級職にアクセスして、理想の仕事を手に入れましょう。
似たような仕事
担当製品のProduct Life Cycle Management · (製品の企画・開発・販売および販売後のサポート・終売まで)に関する業務全般をお任せいたします。 · 上流:製品企画・開発・販売戦略の立案と推進 · (新規製品、既存製品の開発、改良に関する企画及び推進) · (新規製品導入における戦略企画立案および推進) · <商品例> · LUMIPULSEシリーズ(試薬・分析装置)、ESPLINEシリーズ(迅速検査キット)など · ...
1ヶ月前
Work Flexibility: Hybrid or OnsiteThe Job's Mission · Under minimum supervision by Manager, he/she understands the related laws and regulations, and efficiently conducts the duties such approval applications, notifications and other related tasks. · マネジャーの最小の指導の下、薬機法全般に精通し、豊富な知識と ...
3日前
We are seeking a highly motivated Regulatory Affairs Manager to lead regulatory strategies and ensure compliance for pharmaceutical and medical device products. This role plays a critical part in supporting product launches, ...
1ヶ月前
Are you ready to accelerate your potential and make a real difference within life sciences, · diagnostics and biotechnology? · ...
1ヶ月前
The Job's Mission · Under minimum supervision by Manager, he/she understands the related laws and regulations, and efficiently conducts the duties such approval applications, notifications and other related tasks. · マネジャーの最小の指導の下、薬機法全般に精通し、豊富な知識と経験を有し、円滑な薬事申請及び関連業務の遂行を目的とする。 · Ke ...
2日前
Job Description · 業務内容: · グローバル戦略に沿った、効率的かつ付加価値の高い新薬等の国内開発薬事戦略の構築 · 規制当局(厚生労働省、独立行政法人医薬品医療機器 総合機構など)との窓口業務 · 承認申請・審査資料、機構相談資料、照会事項に対する回答等へのレビュー・アドバイスを通じ、当局提出文書の質の向上に資する · 承認申請・審査資料、機構相談資料、照会事項に対する回答等の作成・提出のコーディネーション · 新薬承認申請に関する薬事情報の収集・分析、関係者への提供/共有 · 当局対応(30日調査、対面助言、申請準備、審査対応)の際 ...
1日前
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and profess ...
18時間前
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access equity all. · ...
3週間前
+ Job summary: At Johnson & Johnson we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented treated and cured. · + Qualifications:At least 5 years of pharmaceutical business experience with medical d ...
1ヶ月前
This position is responsible for monitoring and controlling promotional activities in accordance with laws, regulations, and industry self-regulations. The candidate will be responsible for ensuring that promotional materials and related events are in compliance with legal requir ...
1週間前
This position is responsible for conducting scientific evaluations of drug characteristics from a non-clinical perspective, developing domestic development strategies, and preparing materials to meet regulatory requirements. It also contributes to the implementation and approval ...
1ヶ月前
We believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, · `Plan, prepare and execute necessary regulatory actions to support business objectives. · `}`Company's business strategy ...
1ヶ月前
This Is What You Will Do · 担当地区における医療関係者とAlexionの主要窓口として、疾患及び製品の認知度を向上させ、患者様の為に診療環境の整備に努める。 · 担当地区(テリトリー)の状況分析に基づいた効果的なテリトリー戦略立案、戦術実行により設定された営業目標を達成する。 · 希少疾患における市場原理を十分理解し、優先順位の高い施設・医療関係者について具体的な攻略プランを策定、プランに基づくアクションを実行し、随時見直しを行う。 · ...
2週間前
Nonclinica Project Specialist job description and requirements in Japan. · ...
1ヶ月前
At Johnson & Johnson, · We believe health is everything. · Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented,treated,and cured, · where treatments are smarter and less invasive, · and solutions are personal. · ...
1ヶ月前
We are engaged in the research, development and provision of medical technologies in Japan. In particular, we focus on the development of innovative therapies and provide advanced technologies related to cancer treatment. · 医療機器の設計検討、試作・検証、製品化に向けた開発業務全般 · 技術課題の抽出および、改良または新たな解決策の検 ...
3週間前
We're looking for a Principal Specialist to join our QARA team in Tokyo. As a General Marketing Supervisor under the PMD Act, you'll ensure compliance with all applicable QMS and GVP requirements. · ...
1ヶ月前
We are seeking an experienced PK specialist to join our team in Japan. As a PK specialist, you will play a critical role in driving efficient drug development and regulatory registration. · ...
1ヶ月前
This position requires the successful candidate to support the activities in RADDS Japan which includes contributing to the scoping, integrated proposal compilation, and delivery oversight of multi-disciplinary biopharmaceutical development advisory/clinical trial enablement proj ...
1ヶ月前
Summary · 医薬品や再生医療等製品の初期開発段階からプロジェクトチームに参画し、承認取得までの期間を通し、薬事戦略の立案やそれに基づく開発プランの作成、規制当局(MHLW, PMDA)との折衝、Globalと協働しながら世界同時開発、申請/承認をドライブしていくことができます · About The Role · 業務内容: · 医薬品の初期開発段階からプロジェクトチームに参画し、承認取得までの期間を通し、薬事戦略の立案、それに基づく開発プランの作成について中心的な役割を果たし薬事的リスクマネジメントを行う。 · 規制当局(PMDA, MHLW) ...
1週間前