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Senior Manager, Regulatory Affairs

In-Office, Minato-ku, Tokyo

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ID da oferta
R-524102
Category
Regulatory Affairs
Location
Japão
Region
APAC

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT),byapplyingtothis role, you will be applying for a position with Waters.

Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientificexpertiseacross biology, chemistry, and physics. Waterscollaborateswith analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance.Through a shared culture of relentless innovation, Waters’ passionate team of approximately16,000colleaguespartner with customers to turn scientific challenges into breakthroughs that improve lives worldwide. 

ポジション概要

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を担当します。

主な職務内容

・バイオサイエンスおよび診断ソリューション製品に関するグローバルおよびローカルの要件に準拠した薬事戦略を策定・実施する。

・関係規制当局への製品の適時登録および承認を確実に取得する。

・PMDA（医薬品医療機器総合機構）およびMHLW（厚生労働省）との主要な連絡担当者として、良好な関係を構築・維持し、薬事承認取得を促進する。

・薬事専門家チームを率いて管理し、指導、業績評価、キャリア開発を行う。

・事業目標達成を支援するため、研究開発、品質管理、マーケティング、営業などのグローバルおよびローカルチームと部門横断的に連携する。

・規制の変更を監視し、ビジネスへの影響を評価する。

・規制要件および申請戦略に関する戦略的な情報提供と技術的ガイダンスを提供する。

・規制申請に必要な、品質、前臨床、および臨床文書の受理可能性を評価する。

・プロセスを簡素化し、生産性を最適化する。適切な標準業務手順書（SOP）およびシステムを開発、導入、管理する。

求める経験・スキル

・ライフサイエンス、薬学、または関連分野の学士号（上級学位が望ましい）。

・IVDを含む医療機器または診断業界における8～10年以上の規制関連業務経験。

・チームマネジメントと人材育成における実績のあるリーダーシップ経験。

・国内および海外の規制要件に関する深い知識。

・製品開発および承認プロセスにおいて、PMDAおよび厚生労働省との連携経験。

・優れたコミュニケーション能力、交渉力、ステークホルダーマネジメント能力。

・グローバルチームと効果的に連携し、規制戦略を効果的に伝達するための、書面および口頭での優れた英語コミュニケーション能力。

・組織変更または事業移行プロジェクトの経験があれば尚可。

追加情報
この役割は、BDのバイオサイエンスおよび診断ソリューション事業とウォーターズ・コーポレーションの統合計画において、BDの戦略的方向性を支える上で極めて重要です。採用された候補者は、この移行期間を通じて規制チームを率い、規制責任および文書の円滑かつコンプライアンス遵守に基づいた移管を確実に行うことが期待されます。 
この変革を通じてコンプライアンスと事業継続性を維持するためには、規制当局および社内ステークホルダーとの緊密な連携が不可欠です。

WatersとBDのバイオサイエンスおよびダイアグノスティック ソリューションズ事業統合について、弊社ホームページ掲載情報をご参照ください。

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visithttps://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

JPN Tokyo - Minato-ku

Additional Locations

Work Shift

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