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 ...

호소는 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. · ...

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 ...

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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 ...

The 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 ...

As 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 ...

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. We are deepening our commitment to elevating the dialysis experience thr ...

Responsible 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 ...

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 · ...

The Head of Regulatory Affairs in Japan will act as the representative of the regulatory affairs organization to the Japan affiliate and be a member of AbbVie Management Team in Japan. · Accountable for day-to-day management of the regulatory team in Japan. · Develop and manage J ...

Contribute to the overall activities in drug development toward obtaining the marketing authorization and maintenance activities of post marketing products in assigned TA. · Assist developing innovative and high quality regulatory strategies to facilitate regulatory processes in ...

The 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 ...

The 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 ...

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating ...

Responsible for developing the regulatory strategy, preparation and execution of regulatory submissions for innovative products with various tactics to expedite product registrations. · Develop regulatory strategy, preparation and execution of regulatory submissions for innovativ ...

Senior 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 ...

Specialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs. Ability to execute highly complex or specialized projects. Adapts precedent and may make significant departures from traditional approaches to develop solutions. · As th ...

+Job summary · This Regulatory Affairs Specialist will support the establishment and operation of compliance systems for pharmaceuticals quasi-drugs cosmetics ensure business processes comply with Japans Pharmaceutical Medical Device Act Pharmacist Act Cosmetics Act monitor regul ...

The 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 ...

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, regulatory submissions, and post-market activities, whi ...