Responsibility: バイオ品の新薬申請及び市販製品の変更管理におけるCMC薬事戦略を構築する バイオ品の新薬申請及び市販製品の変更管理におけるCMCのレギュラトリーリスクを時宜特定し、対応策を立案する 高品質のCMC承認申請資料を作成する。 規制当局からの照会事項に対してタイムリーな回答作成を行う。 バイオ品の新薬申請及び市販製品の変更管理におけるタイムリーな承認に寄与する 最新のCMC薬事情報の把握と規制当局及び業界への高い影響力を持つ。 Role: GSK Japanの開発品目におけるグローバル統一のCMC承認要件の実現かつ迅速な承認取得を目的としたCMC薬事戦略の構築、並びに市販製品の一部変更承認申請、軽微変更届出において、提言、方針決定、関連部署との交渉、必要に応じリソース配分等を自らも行い上司のサポートも行う。 当局対応において、承認時期への影響、GSKにおける承認後のグローバルビジネス及び国内での市販品の供給への影響等を鑑み、方針決定を行う、あるいはその提言を上司に行う。 他部署との協力業務におけるプロセス上の問題（役割分担等）の解決・調整をリードし、GSKとしてより良いプロセスを構築する、あるいはその提言を上司に行う。 複数の製品に共通のCMC関連課題／問題につき、海外関連部署と必要な協議を行う。 複数のproject team に対してCMC RA を代表したCMC薬事戦略の提案・提言を行う。 業界団体・学術団体等を通じCMCに関する規制調和を推進する。 Basic Qualification Skill 日本語又は英語により円滑なコミュニケーションのできる方 共に学びながら成長したい方 分析化学、有機化学または製剤・薬剤学（特に製造方法あるいはGMP）・生物学に関する知識がある方 Experience 企業での業務経験のある方（分析、製造、CMC薬事、開発等）（3年以上が望ましい） Education/certification/Language 医学、薬学、生物学、物理科学等での学士もしくはそれと同等以上 Preferred Qualification Skill 英語環境での理論構築、読み書き、会話力等 Experience CMC薬事業務の経験 Why GSK?
Leidos is hiring licensed behavioral health professionals to join our Adult Military and Family Life Counseling (MFLC) team to support Camp Fuji, Japan Immediate need Join the mission to support U.S. military service members and their families
At Dow, we believe in putting people first and we’re passionate about delivering integrity, respect and safety to our customers, our employees and the planet. Our people are at the heart of our solutions. They reflect
Purpose & Overall Relevance for the Organization Manage and deliver the Go To Market (GTM) strategy against global priorities; lead category management team to bring the strategy to life Key Responsibilities Deliver business strategy and success
Meta is seeking a strong, experienced Agency Partner to work with leading Japan agencies to help build and sell Facebook and Instagram’s advertising solutions. You’ll contribute to a high-caliber team in a business that is experiencing
We support peace and prosperity by building connections, understanding and trust between people in the UK and countries worldwide. We work directly with individuals to help them gain the skills, confidence and connections to transform their
PURPOSE AND SCOPE: Functions as part of the dialysis health care team in providing safe and effective dialysis therapy for patients under the direct supervision of a licensed nurse in accordance with organization policies, procedures, and training
We help the world run better Our company culture is focused on helping our employees enable innovation by building breakthroughs together. How? We focus every day on building the foundation for tomorrow and creating a workplace
ER24 SBMS Harmony Mponeng Mine | Carltonville | South Africa Closing date: 19/02/2024 Number of positions: 1 Recruiter name: Mina Van Der Merwe Reference number: 47998 Workplace Type: On-site Fixed Term Please note if you are
JOB SUMMARY The Japan Case Management Lead is a member of the Japan PV Operations Leadership Team and reports to the Japan PV Operations Lead. He/She is responsible to implement and manage the case processing operation
Company 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
Role Purpose:This position will drive the execution of Market Access strategies specific to the Edwards BU portfolio of innovative therapeutic solutions for structural heart disease and/or advanced critical care technologies in Japan. The successful candidate will
Mid-Level Electromagnetics Simulation Engineer/ Physicist- Nagoya, Japan Company: Boeing Japan Kabushiki Kaisha Job ID: 00000425819 Date Posted: 2024-06-11 Location: JPN - Nagoya, Japan Job Description Qualifications: (Japanese Follows) Boeing Research & Technology (BR&T) defines, executes and
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich
Return Flight - Mid-Level Electromagnetics Simulation Engineer/ Physicist- Nagoya, Japan Company: Boeing Japan Kabushiki Kaisha Job ID: 00000426774 Date Posted: 2024-06-11 Location: JPN - Nagoya, Japan Job Description Qualifications: (Japanese Follows) Boeing Research & Technology (BR&T)
【障がい者雇用】Mid-Level Electromagnetics Simulation Engineer/ Physicist- Nagoya, Japan Company: Boeing Japan Kabushiki Kaisha Job ID: 00000426789 Date Posted: 2024-06-11 Location: JPN - Nagoya, Japan Job Description Qualifications: (Japanese Follows) Boeing Research & Technology (BR&T) defines, executes and
HOTEL DESCRIPTION Kagoshima is the southwestern prefecture of the Kyushu Island. Major economic pillars of the prefecture include agricultural and food, electronic and automotive-related industries. The Hotel will be part of a mixed-use development that comprises
Position Overview At PNC, our people are our greatest differentiator and competitive advantage in the markets we serve. We are all united in delivering the best experience for our customers. We work together each day to
About the Role: Grade Level (for internal use): 10 Senior Analyst (Corporate Governance & M&A) Background: S&P Global Governance Solutions and M&A team is seeking a highly skilled corporate governance expert for a consultative, advisory, and
