Department:Regulatory CMC Japan Report to:Head,Non-clinical & CMC Dev 1. Act as a key person to coordinate CMC and/or regulatory science issues between global and Japan so that appropriate solutions are provided 2. Be responsible for preparation of Appliation
Job title: Senior Manager, Regulatory Affairs Location: Hatsudai Tokyo About the Job Position Summary The Senior Manager, Regulatory Affairs serves as the Japan regulatory lead for assigned development projects. This role is responsible for formulating and executing Japan regulatory strategies
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
メルクと一緒に、あなたの力を発揮しよう！ 冒険、限界への挑戦、そして発見に焦がれるあなたへ。あなたの大志を、メルクで羽ばたかせましょう！科学とテクノロジーを駆使したイノベーションに情熱を注ぐメルクのスタッフは世界中で活躍中です。ヘルスケア、生命科学、エレクトロニクスの分野で、メルクのソリューションは人々の暮らしをますます豊かなものにしています。あなたとメルクの力を合わせて、大きな夢を抱きましょう。メルクは、人、顧客、患者、そしてこの地球という惑星が共存する豊かな世界の構築に情熱を注いでいます。このためメルクでは、好奇心にあふれた人材を募集中です。メルクと一緒に、想像を超えた世界を開拓しませんか？ 患者さんのためにひとつになって団結し、生命の誕生、QOLの向上、命をつなぐサポートをすることか、ヘルスケアにおける私たちの目的です。私たちは、腫瘍学、神経学、不妊治療などの疾患領域において、医薬品、インテリジェント装置、革新的技術を開発します。私たちのチームは、人生のすべてのステージで患者さんを助けるために、情熱と執拗な好奇心を持って6大陸全体で協力して働いています。ヘルスケアチームに入ることは、多様的で包含的、そして柔軟な職場文化の一部となることです。世界中で個人的な能力開発とキャリアアップの素晴らしいチャンスが待ち受けています。 YOUR ROLE This role provides a unique opportunity to make a significant impact in the pharmaceutical industry while working in a dynamic and supportive environment. As the CMC Regulatory Senior Manager, you will serve
Senior Regulatory Scientist-Tokyo Osaka- Office Hybrid/Home ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and
This is what you will do: The Senior Manager, Regulatory Affairs-Chemistry, Manufacturing, and Controls (RA- CMC) in Japan will manage complex projects for CMC submission in Japan and responses to regulatory agency inquiries for Alexion’s commercial and investigational
Basic purpose of the job: To drive Above-Market Growth and fully leverage the value of key assets within the TA-Cardio Renal Metabolism area, especially Jardiance, and VicaEmpa (CKD and HF) and early assets. This role is
Job Overview: Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports).
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives
Company Description Wise is a global technology company, building the best way to move and manage the world’s money. Min fees. Max ease. Full speed. Whether people and businesses are sending money to another country, spending
To get the best candidate experience, please consider applying for a maximum of 3 roles within 12 months to ensure you are not duplicating efforts. Job CategoryReal Estate & Facility Management Job Details About Salesforce Salesforce
CRA II Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the
Job Description 1. Quality Management of third-party manufacturers and suppliers 2. Quality Operations of EM CHC JAPAN Entity 3. Quality Training 4. Quality Technical Support The EM CHC JAPAN Senior Quality Manager (EM CHC JAPAN -
Roles providing expertise on scientific topics regarding relevant disease areas and Company assets to ensure their safe and appropriate use by patients. Acts as a field-based expert, building relationships with External Experts as trusted scientific partners.
The Medical Science Liaison (MSL) is a field-facing role whose main objectives are to: exhibit a high degree of scientific and clinical knowledge, i.e. a robust knowledge of diseases, vaccinology, product development, clinical trials exhibit a
job title: TALENT AND REWARD OPERATIONS LEAD JOB SUMMARY: The Talent & Reward Operations Lead is responsible for the Local Talent & Reward operations activities. The Lead will manage the local team to ensure all activities
Technical leading regulatory compliance management for Beauty products in Japan: - Engaging in global projects for regulatory affairs digital transformation and support Japan I&S to develop regulatory compliance guideline in line with global digital transformation - Evaluating beauty claims review
Medical safety management of GPV local products: Serve as a clinical and post-marketing medical safety expert in the country Accountable for all signal management activities in the country & ensures that the local product labels and