Regulatory Submissions Jobs in Japan

The Senior Medical Writer is responsible for planning preparing and managing medical writing projects as well as creating and reviewing documents in some instances. Reporting to the Head of Clinical Development Japan the Senior Medical Writer is responsible for the creation and maintenance of docume...

The Team Lead Global Regulatory Affairs CMC - Japan is responsible for providing strategic leadership and operational oversight for the Global Regulatory Affairs CMC - Japan team.Reporting to the Head of Global Regulatory Affairs CMC you will partner closely with Global Regulatory Affairs CMC Japan...

Job PurposeAt GSK we unite science technology and talent to get ahead of disease together. Our goal is to improve the lives of billions across the world. By bringing together outstanding people in an inclusive environment we can make an impact on a global scale.GSK is seeking an experienced Clinical...

Career CategoryClinicalJob DescriptionJob PurposeThis position is responsible for providing statistical expertise and leadership for clinical development and regulatory filing activities in Japan as a member of Global Biostatistical Science Japan Biostatistics.The role will focus primarily on Japan-...

Job Description医薬品開発戦略に対して臨床薬理/ファーマコメトリクスを活用した提案を行い早期承認に貢献する他チームや臨床現場に対して治験薬の臨床薬理学的情報を的確に提供するとともに問題解決を行うプロトコールの試験デザイン被験者数解析方法並びに試料のサンプリングポイントなどを検討し適切な提案を行う薬物動...

Job PurposeManage the Quality Control laboratory and related quality management systems associated with in-process and final release testing Environmental and Utilities monitoring product stability programs and technical transfer of methods.Key ResponsibilitiesThe following key responsibilities appl...

Regulatory Reporting FRA Analyst Own and execute daily / monthly production of FR 2052a FRY14 FRY15 liquidity reports ensuring completeness accuracy and timeliness. Prepare and validate FDIC regulatory reports in compliance with 12 CFR 369 (FDIC reporting requirements) and 12 CFR 370 (recordkeeping...

Galderma is the emerging pure-play dermatology category leader present in approximately 90 countries. We deliver an innovative science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics Dermatologic...

Job PurposeJapan plays a critical role in the growth and success of the GSK organization. This new position is created within the GSK Japan Biostatistics team part of the wider Asia Biostatistics group. The primary responsibility of this role is to support the statistical delivery of clinical resear...

Job PurposeJapan plays a critical role in the growth and success of the GSK organization. This new position is created within the GSK Japan Biostatistics team part of the wider Asia Biostatistics group. The primary responsibility of this role is to support the delivery of clinical research programme...

Career CategoryClinicalJob DescriptionJob SummaryThe Clinical Pharmacology Modeling & Simulation Manager will be responsible for developing and implementing clinical pharmacology strategies to support drug development programs. The successful candidate will be local representative of CPMS for the as...

Position Purpose: The Statistical Scientist provides components of statistical contribution to a clinical development program. The Statistician implements statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables. The position will...

Career CategoryQualityJob DescriptionWHAT YOU WILL DOIn this vital role you will report to the Japan Asia Pacific (JAPAC) Quality Compliance Director within Clinical & Research Quality (CRQ). The Quality Compliance Lead provides proactive end to end quality oversight strategies for the development a...

Be an essential element to a brighter future.We work together to transform essential resources into critical ingredients for mobility energy connectivity and health. Join our values-led organization committed to building a more resilient world with people and planet in mind. Our core values are the...

Be an essential element to a brighter future.We work together to transform essential resources into critical ingredients for mobility energy connectivity and health. Join our values-led organization committed to building a more resilient world with people and planet in mind. Our core values are the...

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...

MISSION :Develop and maintain accounting principles practices and procedures to ensure accurate and timely financial statements.Prepare general ledger for the group closing local FSA closing and local Tax filing.All Finance matter (Controllership Tax Treasury FP&A) of 2 legal entities (COFACE Japan...

Why Join UsBe a hero for our rare disease patientsAt Ultragenyx we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to achieve this goal our vision is to lead the future of rare disease medicine. For us this means goi...

Why Join UsBe a hero for our rare disease patientsAt Ultragenyx we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to achieve this goal our vision is to lead the future of rare disease medicine. For us this means goi...