+仅：department · ） +先 · ...

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 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 ...

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. · ...

本ポジションは、世界的に展開する外資系医療機器メーカーの日本法人における募集です。特に感染症領域や迅速診断技術に強みを持ち、革新的な製品を通じて医療現場の効率化と患者ケアの向上に貢献しています。グローバルとの連携が活発で、柔軟な働き方やワークライフバランスを重視する企業文化が特徴です。 · 新製品の薬事申請および上市戦略の策定 · 既存製品の変更対応・影響評価 · 薬機法対応(業態管理・ライセンス管理) · 業界団体活動への戦略的参加 · FD申請・オンライン申請対応 · 英語文書の読解・報告 · 医療機器または製薬業界での薬事業務経験 · 英語での読み ...

Regulatory Affairs Leader - Consumer Goods · We are looking for a Regulatory Affairs Leader to direct the regulatory team in the consumer goods sector. This important role involves overseeing regulatory compliance for new product launches. · 規制担当チームを指導し、規制要件の遵守を確保 · 製品開発から規制登録までの ...

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 ...

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 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 ...

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 ...

The 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 ...

We 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, ...

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 ...

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 ...

The Associate Director of Regulatory Affairs will oversee regulatory strategies and interactions with key agencies in Japan. · ...

The opportunity to develop regulatory strategy, prepare and execute regulatory submissions for innovative products in Japan, with a strong understanding of local regulatory requirements and experience leading regulatory activities. · Create proactive and robust regulatory strateg ...

This 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 ...

Develop 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: ...

We are seeking intern colleagues for APCO Tokyo office starting from December 2025. Interns will support consultants on various existing and upcoming projects, including translation, online research, news and social media monitoring, and administrative assistance. ...