Life Science Regulatory Management、レギュラリースペシャリストとして業務を行う。東京勤務、週2日在宅ワーク可。 · ...

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 ...

· BD 안세요 전속,Waters Corp.첟BD안세요 전속,Waters Corp. ...

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。 · ...

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. · ...

BDは、ヘルスケア分野における多様なニーズに応える医療技術、デバイス、実験機器を開発する世界をリードする医療技術企業です。感染症の撲滅と治癒を目指す戦いにおいて最先端の研究を提供し国内外の人々に画期的な医療・バイオテクノロジーサービスへのアクセスを向上させるという私たちの使命で、私たちが求めています。 · ...

薬事担当シニアマネージャーは、ライフサイエンス部門の薬事機能を統括し、バイオサイエンス事業部と診断ソリューション事業部の両方を統括します。体外診断用医薬品(IVD)関連規制を含む国内外の規制へのコンプライアンスを確保するための薬事戦略の策定と実行을担当します。 · ...

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Merck is seeking a Regulatory Affairs Expert to perform tasks such as preparation and submission of DMF for APIs and excipients. · ...

+ · + · +h2+bJob summary/b/h2+pThe Senior Manager responsible for all aspects of regulatory affairs for BDB and DS./ppressible for all aspects of regulatory affairs for BDB and DS.+h2+bJob Description Summary/b/h2+pResponsible for all aspects of regulatory affairs +/pposition ove ...

Work with Regulatory Experts on tasks such as DMF preparation and submission for APIs and excipients. · Licensed Pharmacist · Comfortable with routine email communication in English · ...

Merck is looking for Regulatory Affairs Experts to join their team in Japan. · ...

We are seeking a Regulatory Affairs Expert to join our team at Merck. · Maintain regulatory approvals for In Vitro Diagnostics (IVD) and Medical Devices, · Acting as an agent for Foreign Manufacturer Accreditation, · Preparation of DMF for APIs and excipients, · API Import licens ...

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 global leader in animal health Ceva Animal Health believes our success is linked to our passionate people researching developing producing and supplying innovative health solutions for all animals which contributes to the future of our diverse planet. · We are committed to e ...

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 ...

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 ...

We are supporting a global life sciences organization in identifying an experienced Japan Regulatory Affairs Lead (CMC-focused). This role is responsible for defining and executing Japan-specific CMC regulatory strategies, ensuring compliance with Japanese regulations, and leadin ...

Specialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs. · Direct development of product registration submission, progress reports, supplements, amendments or periodic experience reports. · Interact with regulatory agency to e ...

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 ...

The Regulatory Affairs Senior Manager focuses on some of the following activities in Regulatory Affairs Group. This includes leading RA-related Health Authority interactions, preparing Japan NDA activities and HA's review for approval, and managing outsourcing vendors as needed. ...