Regulatory Documents Jobs in Japan

By clicking the Apply button I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment appl...

Role OverviewThe People Business Partner is an individual contributor role responsible for executing people-related processes programs and local compliance activities in Japan with a high degree of reliability and judgment. Based in Tokyo this role reports to the Principal People Business Partner (U...

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...

職務内容 / Job DescriptionProject Physician (PP) is a medical expert who is accountable/responsible for generating clinical development strategy designing clinical development options and delivering successful clinical development programs for AZ assets in Japan.His/Her accountability/responsibilit...

Job DescriptionWe invite you to join our mission of advancing the prevention and treatment of diseases. The purpose of Global Labeling is to drive labeling strategy and ensure high-quality and compliant labeling documents which provide instructions for the safe and effective use of products for pati...

This is what you will do:The Senior Manager Biostatistics is responsible for statistical activities in support ofclinical trials and NDA submission including but not limited to the following:contributing to development strategies trial designs authoring statistical sections ofprotocols preparing sta...

１主な職務における成果責任/ Description of Primary Role & ResponsibilityA. 市販製品治験薬の安全性情報有害事象収集評価 / Collection and Assessment of safety information (adverse event information) of marketed/investigation Pfizer productsB. グローバル安全性データベースへのデータ入力と管理 / Data entr...

Job descriptionPosition Summary:Linguists are key players at TransPerfect. Your particular language skill and subject matter expertise will allow you to create and finalize the end product before it goes to the client. Under the guidance of your manager and in collaboration with Project Managers you...

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...

Career CategoryRegulatoryJob DescriptionGroup PurposeTo prepare scientific and regulatory submission documents that comply with global and local regulatory standardsJob SummaryTo author and gain approval of scientific and regulatory submission documents that comply with global and local regulatory s...

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...

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...

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...

By clicking the Apply button I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment appl...

Job ScopeContribute as a medical writer with primary expertise in clinical documentation while also supporting nonclinical sections as needed. This role leads and supports the development of regulatory documentsincluding CTD modules and briefing documentsand actively participates in strategic regula...

We are seeking an experienced and detail-oriented Manager Regulatory Submission Project Management (RSPM) to join our dynamic team. This pivotal role offers the opportunity to lead the planning execution and review of regulatory operations activities ensuring the successful submission of regulatory...

We are seeking an experienced and detail-oriented Manager Regulatory Submission Project Management (RSPM) to join our dynamic team. This pivotal role offers the opportunity to lead the planning execution and review of regulatory operations activities ensuring the successful submission of regulatory...

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are unique...

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 PurposeThe Clinical Scientist (CS) in Japan is the single point accountability for the development of the Clinical Development Plan (CDP) study design governance and interpretation of results of the studies and filing strategy and key messages in CTD (clinical modules) for Japan. The study desig...