Lead, Regulatory Affairs

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Key Responsibilities

Pipeline and On-Market Products Development and Maintenance from Regulatory perspectives

• Responsible and accountable for Renal Business Unit new product introduction and sustain product operation activity.
• Plan and execute necessary activities relating to drugs and medical devices.
• Establish regulatory strategy linked to global regulatory and sales marketing strategy.
• Manage regulatory activities relating to specific portfolio of products/projects

薬事的観点からのパイプラインおよびオンマーケット製品の開発と維持管理

• 腎臓ビジネスユニットの新製品導入および持続的な製品運用活動。

• 医薬品および医療機器に関する必要な活動を計画、実行。

• グローバルな薬事・営業マーケティング戦略と連動した薬事戦略の策定。

• 特定の製品／プロジェクトに関する薬事活動の管理。

Qualifications / Experiences

• Academic degree: Bachelor's degree in a scientific or chemical discipline, pharmaceutical, engineering, or related field. Master's and/or PhD degree is preferred.
• Experience: 3 years of pharmaceutical drug registration/medical device registration with concrete experience to prepare CTD/STED

• 学位: 科学または化学分野、製薬、工学、または関連分野の学士号。修士号および/または博士号が望ましい。
• 経験:医薬品登録/医療機器登録の3年以上の経験、CTD/STEDの準備に関する具体的な経験。

Skills

・General Management skills

・People management skill

・English: Strong written, verbal communication and presentation skills (TOEIC 750)

・Knowledge

　-Strong knowledge of regulatory affairs principles, regulations, and guidelines, particularly in the relevant industry.

　-Excellent understanding of the product development process and the ability to apply regulatory requirements to each stage.

　-Exceptional attention to detail and ability to review and interpret technical documentation, scientific data, and regulatory guidelines accurately.

・一般的なマネジメントスキル

・ピープルマネジメントスキル

・英語：筆記、口頭でのコミュニケーション、プレゼンテーション能力(TOEIC 750点)

・知識

　-関連業界における規制関連業務の原則、規制、ガイドラインに関する深い知識。

　-製品開発プロセスに関する優れた理解と、各段階に規制要件を適用する能力。

　-技術文書、科学データ、および規制ガイドラインを正確にレビューおよび解釈する能力。

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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