This is what you will do: The Senior Manager, Regulatory Affairs-Chemistry, Manufacturing, and Controls (RA- CMC) in Japan will manage complex projects for CMC submission in Japan and responses to regulatory agency inquiries for Alexion’s commercial and
Job Description SummaryDevelop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Has knowledge of best practices and
Our Mission At Palo Alto Networks®, we’re united by a shared mission—to protect our digital way of life. We thrive at the intersection of innovation and impact, solving real-world problems with cutting-edge technology and bold thinking.
The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock
The Japan Project Head (JPH) would be responsible for overall Japan development strategy for vaccine project in alignment with Global project strategy as well as Sanofi R&D strategy and business objectives. The JPH is accountable for
Position Summary: The Regulatory Affairs Manager will lead regulatory assessment and execution of post-approval changes for products in Japan, collaborating with internal teams, global colleagues, and external partners to ensure compliant and timely change controls. This
Job title: CMC Regulatory Manager Location: Hatsudai, Tokyo About the job Role & Responsibilities The incumbent regulatory professional is accountable for Japan strategic management of a portfolio of development projects and post-marketed products within Global regulatory
Job Description Position Overview The Specialist, Quality Systems & Compliance is an individual contributor who supports key GQP Quality Assurance activities on behalf of the Marketing Authorization Holder (MAH). The role plans and executes assigned quality
Company Description Arista Networks is an industry leader in data-driven, client-to-cloud networking for large data center, campus and routing environments. What sets us apart is our relentless pursuit of innovation. We leverage the latest advancements in
Our Mission At Palo Alto Networks®, we’re united by a shared mission—to protect our digital way of life. We thrive at the intersection of innovation and impact, solving real-world problems with cutting-edge technology and bold thinking.
職種 正社員 職務明細 製薬業界向けにスマートファクトリーソリューションの導入・推進を担うソリューションアーキテクトを募集しています。本ポジションでは、日本の製薬企業の製造現場のデジタル化を支援し、オートメーション、製造IT、品質ITを組み合わせたエンドツーエンドのソリューションを提供します。顧客の業務要件の整理から設計、導入、テスト、運用サポートまでの全工程をリードし、MES・QMS・LIMSなどのMOMアプリケーションを活用した最適なアーキテクチャを構築します。 本プロジェクトでは、日本国内の製薬企業向けにスマートマニュファクチャリングサービスを提供するチームを拡大しており、今後の事業成長に伴い大きな活躍の機会があります。オートメーションや製造IT分野の専門知識を深めながら、グローバル企業であるTCSのプロジェクトを通じてキャリアアップを目指すことができます。将来的には、ソリューションリード、プロジェクトマネージャー、COE責任者などのポジションへの成長も期待されています。 タタコンサルタンシーサービシズ（TCS）は、ITサービス、コンサルティング、ビジネスソリューションのグローバル企業です。複雑化するIT環境をシンプル化し、さらに進化させることで、お客様のビジネス変革をサポートします。業界に関する豊富な知見や、世界中に広がる研究所・デリバリーセンターを駆使し、お客様にとって最高レベルの品質と満足を提供します。ビジネスを変える。よりよい社会に貢献する。TCSでなら、世界中のテクノロジーと業界知識で、あなたの夢がかないます。 スキル・資格 ■ Must Requirements／必須要件 - 8–12 years of experience in implementing MOM applications such as MES, QMS, and LIMS - Strong understanding of business processes in industries such as Pharma
Appealing Points: Work on advanced OT and automation systems in a GMP-regulated pharmaceutical manufacturing environment. Gain hands-on experience with SCADA, industrial control systems, network infrastructure, and IT/OT integration projects. Play a key role in site operations, continuous improvement
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we