Regulatory Authorities Jobs in Japan

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionEssential Duties and ResponsibilitiesRole Summary:Plan and drive overall quality assurance manufacturing control and safety management activities for handled products and services in compliance with QMS GVP and the Pharmaceu...

Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products while taking a step further in your professional career.Your role:Prepare clinical trial documents for Regulatory and Ethics su...

As Snr Technical Quality (TQ) Analyst - Japan you will have the opportunity to be a part of the Global Operations Quality team to support our North Asia customers.You will ensure alignment with corporate quality processes in the region including warehouse facilities and tollers and provide quality...

JOB DESCRIPTION:Position SummaryThe Regulatory Affairs Senior Specialist is responsible for executing and coordinating global regulatory activities for in vitro Diagnostics (IVD) products for which the company serves as the Legal Manufacturer. The role supports product launches market expansion an...

Career CategoryRegulatoryJob DescriptionHOW MIGHT YOU DEFY IMAGINATIONAmgen is a global leader in biotechnology with a history of more than four decades of pioneering breakthroughs. Our commitment to science has led us to discover and develop innovative therapies that significantly improve patients...

Job Description SummaryProvides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch premarket submissions/registrations and postmarket compliance working closely with healthcare regulatory bodies -depth understanding of key busin...

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight aga...

MAIN REPONSIBILITIES / DUTIESJOB POSITION PURPOSEThe MAS roles are hybrid in responsibilities. Specific roles in teams can vary between 80% field with 20% head office activity to 80% head office activity with 20% field activity. This is a continuum and not fixed and will vary based on business needs...

Amazon seeks an experienced Safety Manager to join our Workplace Health & Safety (WHS) team in pursuit of our vision to become Earths safest workplace. The successful candidate will serve as a key member of the WHS Program Management team leading network-level safety risk mitigation injury preventio...

Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards Cold Room/Freezers -22degreesF/-6degrees C Office Warehouse Will work with hazardous/toxic materialsJob DescriptionJOB CODE: .M05JOB PROFILE: Team Leader QABAND: 5As part of th...

Job Description SummaryThe Japan Customs Leader is responsible for end to end execution and governance of import customs operations for GE HealthCare Japan ensuring regulatory compliance uninterrupted import clearance and strong audit readiness in a highly regulated environment.The role operates wit...

Expert Consultant ToxicologyLabcorp is seeking an Expert Consultant Toxicology to join our team in Tokyo or Remote within Japan.Job Responsibilities: Act in Toxicology Expert Consultant Role train mentor and advise junior staff in area of expertise and/or regulatory matters.Provide customer advice...

Amazon Logistics (AMZL) is responsible for Amazons last-mile delivery and operates a large-scale network across Japan by combining multiple types of delivery nodes. Through Delivery Stations (DS) Amazon Partners Logistics (AMPL) eXchange Point (XPT) and Sub Same-Day delivery station (SSD) we continu...

Title:PV & PMS Manager / AssociateCompany:IPSEN K.K.About Ipsen:Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs...

Job OverviewThis leadership role Director Regulatory Affairs Japan will be a key member of the Japan R&D Development team; Implementation and maintenance of Japan regulatory processes systems and operations in Japan; This role will be responsible for Japan Regulatory strategy for all products. Respo...

職務内容Description: The PS Epidemiologist (PSEPI) serves as a study lead for Post Authorization Regulatory Commitment Studies (PARCS) including post-marketing database study and use-result survey accelerating the generation of valuable real-world evidence. Leveraging extensive clinical research exp...

Job SummaryAre you passionate about advancing health and wellness through innovative bioscience solutionsIFF is a global leader in flavors fragrances food ingredients and health & biosciences. We deliver sustainable innovations that elevate everyday products.Health & Biosciences (H&B) is dedicated t...

ジェンマブは革新的な抗体医薬の開発に注力し患者さんの生活を改善することに力を尽くしています私たちはextranotordinary な未来を共に築くことを使命とし革新的な抗体製品の開発や人々を感動させる抗体医薬品でがんやその他の深刻な病に苦しむ患者さんの生活を根本的に変え治療の未来を切り拓いていますジェンマブは思い...

Job Description業務内容1. グローバル戦略に沿った効率的かつ付加価値の高い新薬等の国内開発薬事戦略の構築2. 規制当局厚生労働省独立行政法人医薬品医療機器 総合機構などとの窓口業務3. 承認申請審査資料機構相談資料照会事項に対する回答等へのレビューアドバイスを通じ当局提出文書の質の向上に資する4. 承認申請審査...

MAIN REPONSIBILITIES / DUTIESJOB POSITION PURPOSE The MAS role family comprises a variety of medical scientific specialties such as BU Medical and field based Medical.Be the Pfizer Japan medical scientific point of contact for HCPs medical societies regulators academia and other external stakeholder...