Work Flexibility: Hybrid or Onsite Key Areas of Responsibility: Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature
職務の目的および主な業務内容 Job Purpose & Key Responsibilities スペシャルティ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。 より難易度の高いプロジェクトや国内外ともにステークホルダーが多いプロジェクトにおいて以下を行う。 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 医薬品等の新薬開発関連業務 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
At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system, we touch nearly 20% of the world’s investable assets. Every day
About Anthropic Anthropic’s mission is to create reliable, interpretable, and steerable AI systems. We want AI to be safe and beneficial for our users and for society as a whole. Our team is a quickly growing
The TP ICAP Group is a world leading provider of market infrastructure. Our purpose is to provide clients with access to global financial and commodities markets, improving price discovery, liquidity, and distribution of data, through responsible
Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials
Join us now as Sales Support in Japan within the Japan Retail Sales, Distribution AP. In this role, you will be responsible for creating the documents which the outsourcing service provider provides for AGI Japan collaboratively,
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
企業概要 Turner & Townsend is a global professional services company with over 22,000 people in more than 62 countries. Working with our clients across real estate, infrastructure, energy and natural resources, we transform together delivering outcomes
企業概要 Turner & Townsend is a global professional services company with over 22,000 people in more than 62 countries. Working with our clients across real estate, infrastructure, energy and natural resources, we transform together delivering outcomes
Overview The EHS (Environment, Health & Safety) Manager – Japan is responsible for establishing, implementing, and managing EHS programs in compliance with Japanese regulatory requirements and corporate standards. This role supports all Waters sites (except manufacturing) across
Since we opened our doors in 2009, the world of commerce has evolved immensely, and so has Square. After enabling anyone to take payments and never miss a sale, we saw sellers stymied by disparate, outmoded
Company Description Turner & Townsend is a global professional services company with over 22,000 people in more than 62 countries. Working with our clients across real estate, infrastructure, energy and natural resources, we transform together delivering
Company Description Turner & Townsend is a global professional services company with over 22,000 people in more than 62 countries. Working with our clients across real estate, infrastructure, energy and natural resources, we transform together delivering
Our global teams took on the challenge to make a difference in the way the global financial markets operate. Would you seek the same challenge? At LSEG, we help our customers achieve success by providing access
Minimum qualifications: Bachelors degree in Computer Science or equivalent practical experience. 10 years of experience with cloud native architecture and cybersecurity in a customer-facing or support role. Experience delivering technical presentations and live demonstrations for security
Calling all innovators – find your future at Fiserv. We’re Fiserv, a global leader in Fintech and payments, and we move money and information in a way that moves the world. We connect financial institutions, corporations,
Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century’s most innovative companies to
Why this role is important to us The team you will join is central to State Street’s global success. Institutional investors rely on us to manage risk, navigate complexity, and improve performance. In this role, you
Your Opportunity at ARC’TERYX As Security and data protection Officer for Arc’teryx Korea, you will be at the forefront of our digital transformation—empowered to build, lead, and innovate with direct support from the Arc’teryx Technology Global