ERM Japan was established in 1999 and has developed a strong presence and reputation in the provision of environmental and safety services over the past 25 years. Our fully staffed office of with over 100 bilingual
ERM Japan is seeking a motivated Managing Consultant who is interested in participating on a variety of projects covering the full spectrum of ERM’s services. The role will be based in Yokohama or Tokyo, Japan. This
【Job Responsibility】 Highly skilled and high potential leader with a proven track record of delivering results in progressive roles to join our team. Have the opportunity to shape and drive a sustainable and high-performing financial accounting
Do you have a strong background in non-clinical activities? We are looking for a Non-Clinical Expert to join our team at Novo Nordisk. If you are ready to contribute to the development, submission, and approval of
Are you interested in a regulatory affairs role that allows you to mitigate risk and accelerate compliance across the business? If so, this Regulatory Compliance Manager could be an ideal opportunity to explore. As a Regulatory Compliance Manager Professional,
About TaskUs: TaskUs is a provider of outsourced digital services and next-generation customer experience to fast-growing technology companies, helping its clients represent, protect and grow their brands. Leveraging a cloud-based infrastructure, TaskUs serves clients in the
This position involves applying a proven understanding of CMC elements and regulatory requirements to support, and provide guidance to Oncology/ Hematology teams in Japan. This position also supports all CMC regulatory filing activities including the preparation of the
Job Description AirAsia X is seeking dynamic and competent Station Manager - Haneda (HND) to be part of the best airline team in the sky! The overall purpose of the job is to ensure effective and
Safety Manager Safety Manager Safety Manager with ASGHAL experience or approved Locally available candidates with Freelance visa 10 Hrs/ 6 Days Key Responsibilities: Develop and implement safety policies and procedures in accordance with local, state, and
Manage overall accounting functions, including accounts payable, expense reports, treasury, inter company transactions, inventory, and fixed assets, while ensuring accurate SAP entry for vendor invoices and processing Concur expense reports. Additionally, prepare financial statements, assist with
Take lead in RA activities to obtain product approval. Ensure effective submission requirements as well proper timelines of new/existing regulatory projects. Client Details * One of the top global pharmaceutical companies in the industry * Specializing in
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
Be part of one of the leading biopharmaceutical companies in the industry. Take lead in RA development strategies as well as lead the RA team. Client Details * Be part of one of the top global
Take lead in RA activities to obtain product approval. Ensure effective submission requirements as well proper timelines of new/existing regulatory projects. Client Details * One of the top global pharmaceutical companies in the industry * Specializing in
Be part of one of the top global pharmaceutical businesses in the industry. Take lead in GCP audits for the company to ensure regulatory compliance. Client Details * One of the top global pharmaceutical companies in the
Be part of one of the top global biopharma business in the industry. Take lead in QA activities for the business to ensure effective compliance. Client Details * Be part of one of the top global
About us BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse
ワクチン、オンコロジー領域での新薬の承認取得を通して、日本の患者さんにイノベイティブな治療を提供することに貢献できる業務です。 新薬開発及びライフサイクルマネジメントにおいて、薬事戦略を立案/実行する。 薬事関連規制や関連する事例等を考慮した薬事戦略を立案し、チームメンバーと協働して実行する。 承認申請や対面助言等、薬事関連業務をリードし、規制当局との交渉戦略を立案/実行する。 薬事的課題を分析し、適切な解決策を提案/実行する。 海外チームと良好な信頼関係を築き、薬事関連規制や薬事戦略の提供を実行する。 海外薬事規制等を踏まえた国内薬事規制の問題点を提示する。 規制当局と良好な信頼関係を築き、適切なコミュニケーションと薬事的交渉を実行する。 規制当局との交渉の場において議論内容をリードする。 ※職務内容および勤務地の変更範囲は会社の定めるところとする。 必要な条件 Basic Qualification スキル Skill 薬機法の体系、開発・承認審査の概略に関する知識 プロジェクトチームや規制当局で開発薬事戦略を説明するコミュニケーション力 グローバルコミュニケーション力（英語での理論構築、読み・書き・会話力） 経験 Experience 医薬品等の開発関連業務に合計3年以上携わった経験 学位/資格/語学力 Education/Certification/Language 医学、薬学、生物学、科学等での学士もしくはそれと同等以上 望ましい条件 Preferred Qualification スキル Skill ロジカルシンキング 既成概念にとらわれない思考 変化を積極的に受け入れ、挑戦し、実行する姿勢 経験 Experience 医薬品等の承認申請・対面助言関連業務 学位/資格/語学力
Job Title:Reliability Engineer Summary:•This position is responsible for the safe and efficient maintenance work with facility modification of the Ohta site. Responsibility includes process efficiencies, reliable engineering, project management support, supporting business growth with timely manner
ERM is seeking a Managing Consultant to join our growing Environmental Health and Safety technical team in Osaka, Japan. In this role, you will provide technical assistance on health and safety compliance projects, safety oversight, risk
