About Revolut
People deserve more from their money. More visibility, more control, and more freedom. Since 2015, Revolut has been on a mission to deliver just that. Our powerhouse of products — including spending, saving, investing, exchanging, travelling, and more — help our 60+ million customers get more from their money every day.
As we continue our lightning-fast growth, 2 things are essential to our success: our people and our culture. In recognition of our outstanding employee experience, we've been certified as a Great Place to Work. So far, we have 10,000+ people working around the world, from our offices and remotely, to help us achieve our mission. And we're looking for more brilliant people. People who love building great products, redefining success, and turning the complexity of a chaotic world into the simplicity of a beautiful solution.
About the role
レギュラトリー・アフェアーズ(Regulatory Affairs)チームは、各国の規制当局との透明性の高い信頼関係を維持・構築していく役割を担っています。
現在、グローバルに事業を拡大していく中で、日本の規制環境に対応しながら、当局との関係構築・管理をリードしていただけるレギュラトリー・アフェアーズ・マネージャー(Regulatory Affairs Manager)を募集しています。
What you'll be doing
- 規制当局や社内へのわかりやすいコミュニケーションの実施(複雑な内容も、簡潔かつ明確に伝える力が求められます)
- 新しい商品や取り組みについて、規制当局への定期的な情報共有・報告
- インシデント対応時に、リスク・コンプライアンス部門と連携し、当局とのコミュニケーションを調整
- 経営会議・社内委員会・取締役会向けの資料作成や報告レポートの作成
- 社内のプロダクトチームや各部門に対し、規制要件や変更点に関する研修・情報提供
- チーム全体で活用できるような業務プロセスやドキュメントの構築
- 会社全体における誠実なビジネス慣行(コンダクト)とコンプライアンス文化の推進
What you'll need
- 日本国内の金融機関における業務経験(7年以上)
- 金融庁、財務局、日本銀行などの規制当局との折衝・対応経験が豊富な方
- 金融機関がどのように監督されているか、またグループのRegulatory Affairsチームの機能に関する理解
- 自主的に動き、自己管理と高い成果へのこだわりを持って業務を遂行できる方
- 複雑な事柄でも、簡潔に要点を伝えるコミュニケーションスキル
- 優先順位が変わる状況でも、柔軟かつ主体的に対応できる能力
- 多様なチームや異なる立場のステークホルダーと、相互尊重に基づいた関係構築ができる方
-
Tokyo, Tokyo Parexel ￥1,500,000 - ￥2,500,000 per yearパレクセルコンサルティング(薬事部門)は、主に海外のバイオテックカンパニーをクライアントとして、新薬開発計画の戦略プランからPMDA相談、申請、承認取得までのサービスを提供しております。 · クライアントの窓口となり、業務依頼(Statement of Work、予算、要求、期待値)を確認し、プロジェクトの範囲と要件を理解。 · 必要に応じ、クライアントとの会議を設定、ファシリテートし、薬事サービスに関するニーズ、問題点につき話し合い、戦略的計画を立てる。 · プロジェクトチームの発足からプロジェクト終了までの全てのプロセスにおいて、タイムライン、コスト ...
-
Tokyo BD ￥9,000,000 - ￥12,000,000 per year+仅：department · ） +先 · ...
-
Minato-ku BD Full time￥6,000,000 - ￥12,000,000 per year호소는 정을 안세요 - · BD's Life Science Department (BioScience and Diagnostic Solutions Business) is integrating with Waters to become a leading company in the life science and diagnostic fields, specializing in high-volume testing in a highly regulated market. · ...
-
Tokyo BD ￥2,024,000 - ￥30,000,000 per year当社のライフサイエンス製品に関する薬事業務全般をご担当いただきます。具体的には以下の業務を担っていただきます。 · 製品登録プロジェクトのリード · (医薬品医療機器等法)に基づく登録申請書類の作成・提出 · 償還関連業務 · 区分の償還申請書類の作成・提出、E2・E3区分の償還取得サポート · 製品ラベリングのレビュー・承認 · 登録書類と整合性を保つためのラベルや関連資料の確認 · 広告・販促資材(AdProm) のレビュー・承認 · 事業部門:ビジネス戦略を理解し、薬事戦略や進捗を共有 · Regulatory(海外):製品登録に必要な情報のはて ...
-
Tokyo Parexel Full time￥6,000,000 - ￥12,000,000 per yearパレクセルコンサルティング(薬事部門)は、主に海外のバイオテックカンパニーをクライアントとして、新薬開発計画の戦略プランからPMDA相談、申請、承認取得までのサービスを提供しております。 · クライアントの窓口となり、業務依頼(Statement of Work、予算、要求、期待値)を確認し、プロジェクトの範囲と要件を理解。 · 必要に応じ、クライアントとの会議を設定、ファシリテートし、薬事サービスに関するニーズ、問題点につき話し合い、戦略的計画を立てる。 · プロジェクトチームの発足からプロジェクト終了までの全てのプロセスにおいて、タイムライン、コスト ...
-
Tokyo, Tokyo GE HealthCare ￥6,000,000 - ￥12,000,000 per yearWe 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, regulatory submissions, and post-market activities, whi ...
-
Tokyo, Tokyo iNova Pharmaceuticals ￥4,500,000 - ￥8,000,000 per yearThe Company is seeking a Regulatory Affairs Manager to join its team on a full-time basis. The position is responsible for setting & executing the Japan regulatory strategy, managing product registration and maintenance, local regulatory support for the new product launch and loc ...
-
Tokyo Michael Page ￥3,500,000 - ￥7,000,000 per yearアジア・欧州など75以上の国と地域に展開する製品に関与 · 革新的で患者中心の製品を提供するヘルスケア企業。世界75以上の市場で展開しており、科学的根拠に基づいた製品ポートフォリオを持つ成長企業です。 · 日本市場における薬事戦略の立案・実行 · 製品登録・維持管理、申請スケジュールの策定と進捗管理 · 薬事関連法規(PMD Act等)の情報収集と対応 · 新製品導入に向けた薬事支援、技術情報の収集・提供 · グローバル・ローカルプロジェクトへの参画・支援 · ...
-
Tokyo Revolut ￥5,000,000 - ￥15,000,000 per yearWe are looking for a Regulatory Affairs Manager to lead our team in Japan, responsible for maintaining and building transparent relationships with regulatory authorities. The successful candidate will have experience in the financial industry, particularly in regulatory affairs, ...
-
Regulatory Affairs
2週間前
Tokyo, Japan ZOLL Medical $90,000 - $120,000 per yearThe Regulatory Affairs Manager is responsible for overseeing the preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities. This position will also oversee the preparat ...
-
Regulatory Affairs
1週間前
Tokyo ZOLL Medical Corporation ￥5,500,000 - ￥10,000,000 per yearThe Regulatory Affairs Manager is responsible for overseeing the preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities.This position will also oversee the preparati ...
-
Tokyo ICON plc ￥800,000 - ￥1,200,000 per yearSenior Manager, Regulatory Affairs - Tokyo Osaka Remote/office hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mis ...
-
Japan Ceva Sante Animale ￥2,500,000 - ￥5,000,000 per yearAs a Regulatory Affairs Manager, you will ensure regulatory submissions and post-licensing compliance for Ceva products in Japan. You will coordinate activities, apply regulations, and develop a regulatory strategy. You will also manage quality systems, pharmacovigilance activiti ...
-
Shinjuku Cordis Full time￥5,000,000 - ￥10,000,000 per yearThis position will be responsible for leading all medical device Regulatory Affairs activities which include product submissions, develop regulatory strategies, change assessments, commercial supports, compliance related activities, systems/process improvements and other responsi ...
-
Japan Colgate ￥5,000,000 - ￥10,000,000 per yearResponsible for supporting Associate Director Regulatory Affairs EMEA/Japan to ensure compliance with regulations and statutes concerning development, manufacturing, distribution, marketing and sales of Hill's products in Japan. Develops creative approaches and strategies to solv ...
-
Tokyo, Tokyo Merck Healthcare ￥5,000,000 - ￥10,000,000 per yearDevelop and execute regulatory affairs (RA) activities from the development to the life cycle management, with collaborative with global and Japan stakeholders. Regulatory Affairs Senior Manager focuses on some of the following activities in Regulatory Affairs Group 1 or Group 2: ...
-
Tokyo, Tokyo Planet Pharma ￥4,000,000 - ￥8,000,000 per yearThe Senior Regulatory Affairs – CMC Specialist will be responsible for leading and supporting Chemistry, Manufacturing, and Controls (CMC) regulatory activities related to product development, registration, and lifecycle management for the Japanese market. · Author, review, and m ...
-
Tokyo Sandoz ￥80,000 - ￥120,000 per yearThe purpose of internship is to provide students who are interested in pharmaceutical industry with practical experience in regulatory affairs. · Through Hands-on Experience And Mentorship, Participants Will Gain insight and practical experience in the role of regulatory affairs ...
-
Tokyo ZOLL Medical Corporation ￥6,000,000 - ￥9,000,000 per yearThe Regulatory Affairs Manager is responsible for overseeing the preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities.This position will also oversee the preparati ...
-
JP, Tokyo Solventum ￥1,240,000 - ￥2,400,000 per yearSolventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. We pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives ...
-
Japan - Tokyo Amgen ￥1,500,000 - ￥2,000,000 per yearThe Associate Director of Regulatory Affairs will oversee regulatory strategies and interactions with key agencies in Japan. · ...
