- Submission of global regulatory documents
- Compilation and archiving of regulatory submissions
- Assistance with setting up submission templates and troubleshooting MS Word, Adobe PDF documents, electronic document management system, publishing tool, and databases
- Function as a publishing resource for Regulatory Affairs
- Maintenance and control of regulatory submission electronic filing system, user management, and correspondence logs
- Creation and management of SOPs/Work Instructions/User Guides affecting job function
- Assistance with Document Control Room activities
- Assistance with computer system validation activities
- Interaction with external vendors, regulatory team members, cross-functional departments and teams
- Management of special projects as necessary
- Fluent Japanese and English communications skills, both orally and in writing
- Knowledge of Microsoft Office Suite, Adobe, and databases
- Working experience in the Pharmaceutical industry
- Ph.D, Master or Bachelor degree of Pharmacy
- One to two years of office experience required
- Associate's Degree or equivalent industry experience
- Strong organizational skills and attention to detail
- Ability to understand and adhere to document control procedures
- Strong proofreading skills and ability to recognize deviation from accepted practice
- Ability to work as a team player when assigned to a project assignment
- Ability to focus despite distractions and changing priorities
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Osaka Santen Inc Full timeRegulatory Operations, Specialist · Full-time · Company Description · Position can be based at any Japan Santen office. Open only to internal applicants. Please submit English CV. · Steps: · screening→SPI→CV review→explaining session→1st ITV→2nd ITV · Job Description · This ...
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Osaka Equinix Full timeWho are we? · Equinix is the world's digital infrastructure company, operatingover 250 data centers across the globe.Digital leaders harness Equinix's trusted platform to bring together and interconnect foundational infrastructure at software speed. Equinix enables organizations ...
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Osaka IQVIA Full timeJob Description · SummaryJob Overview · With global impact and oversight, manage a department of Biostatistics and Statistical Programming staff ensuring that target productivity (project allocations, utilization, and output) levels are met. May fulfill the role of site head or ...
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Osaka Hong Leong Bank Berhad Full timeIf you are looking to excel and make a difference, take a closer look at us... · Functional (job responsibilities) · Operations · Ensure escalation of non-compliance related lapses i.e. internal breach of SOP and regulatory breaches to all relevant parties immediately. · Approv ...
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Osaka TOK Fortrea Japan kk (Co., Ltd. in English) Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and techn ...
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Osaka Santen Inc Full time[GLOBAL] General Manager, Quality Compliance Audit Group · Full-time · Company Description · Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 co ...
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Osaka Global Blue Full timePurpose of the role · Global Blue is a global company operating, amongst others, in the field of VAT refunds to travellers, and is a leading company with the largest amount of TFS transactions in Japan. · Field Service team is responsible for providing frontline user and custome ...
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Osaka Kuehne+Nagel jobs.contract_type_full_time, PermanentJOB DESCRIPTION You will be joining our Customer Care Team to add your expertise + skills to the delivery of Customer Excellence. Your Role · You will support customers by providing helpful information, answering questions + working closely with the Operational Key Account Ma ...
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Osaka Oracle Regular EmployeeAs a Solution Engineer, your primary responsibility will be to propose solutions to large manufacturing clients. You will work closely with the sales representative from a technical perspective, collaborating with product specialists and consultants to lead technical proposals fo ...
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Osaka Kuehne+Nagel jobs.contract_type_full_time, PermanentJOB DESCRIPTION You will be joining our Customer Care Team to add your expertise + skills to the delivery of Customer Excellence. Your Role · You will support customers by providing helpful information, answering queries, + responding to complaints and feedback.Utilizing your ...
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Osaka AIG Full time職務目的(Job Purpose) · 担当地区において、上席者の管理・監督の下で「基幹商品ALLSTARs」を中心とした推進および引受業務を通じて、お客様に寄り添いお守りするなかで、企業賠償保険ラインの成長ならびに収益性の最大化を図る。 · 職責(Job Responsibilities) · 担当地区(大阪駐在にて関西地域事業本部担当予定)の企業賠償保険ラインの予算達成に責任を持ち、そのために地域事業本部・他ラインの駐在スペシャリスト等と連携・協働し、担当地区のマーケット、チャネルの状況に応じた「基幹商品ALLSTARs」の販促(契約保全を含む)につ ...
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Osaka Takeda Full timeDescription · ABOUT TAKEDA · "Better Health for People, Brighter Future for the World" is the purpose of a company. We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to inn ...
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ICF Lead
1週間前
Osaka IQVIA Full timeAt a global level, drive Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines to develop the informed consent form (ICF), including dur ...
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Osaka Uplift People ConsultingAbout Uplift · Uplift is a dynamic agency specializing in global talent search, covering EMEA, LATAM, USA, and APAC. With successful placements in 52 countries, we combine speed and cutting-edge technology to source top executive and mid-senior talent across various functions. Ou ...
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Osaka Takeda Full timeDescription · ABOUT TAKEDA · "Better Health for People, Brighter Future for the World" is the purpose of a company. We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to inn ...
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Osaka Santen Inc 正規雇用Cybersecurity Architect, Global Information Security · 正規雇用 · 会社概要 · Santenは、眼科医療に特化した130年の歴史を持つ製薬企業です。日本発のグローバル企業として60カ国以上に拠点を持ち、目の健康のために様々な革新的な治療法とデジタルソリューションを提供し、世界中の人々の視覚に関わる社会問題に取り組んでいます。 · 求人内容 · Job's mission · Under the direct supervision and guidance of the Cybersec ...
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Osaka FedEx jobs.contract_type_full_time, jobs.contract_type_full_timeApplies specialised expertise to execute and review specific processes and procedures within and across departments, supporting the achievment of divisional and corporate objectives. Actively participate in or lead the design, development, and implementation of processes within t ...
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Osaka Santen Full time求人内容 · Job's mission · Under the direct supervision and guidance of the Global Head of Information Security, the job holder is part of the Global Information Security (Digital & IT Division), responsible for leading the implementation & execution of Global Cyber Defense Strategy, ...
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Osaka Turner & Townsend Full timeCompany Description · Who is Turner & Townsend? · All over the world people are using buildings, infrastructure, and assets we helped to deliver. It could be the hospital they work in, the railway they travel on every day, the fuel that powers their car or the data centre they ...
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Chuo Astellas Pharma Inc. PermanentDescription 【Purpose & Scope】 Responsible for managing and executing the Technology and Data Quality Assurance (TDQA)audit and validation oversight programs related to regional Astellas Information Systems processes for computer systems, technology solutions, clinical and commerc ...
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Chuo Astellas Pharma Inc. PermanentDescription 【募集の背景 / Purpose & Scope】 · •Have ultimate responsibility and accountability for clinical pharmacology from first-in human through approval, including post-marketing activities for assigned projects · •Therapeutic optimization and individualization (right dose for r ...
