Job Title Regulatory Affairs Manager Job Description Job title:One sentence description of role Your role:• The greater impact of this role. • Detail elements of the team and stakeholders for this role. • What are the professional and
About the Team OpenAI’s mission is to ensure that general-purpose artificial intelligence benefits all of humanity. We believe that achieving our goal requires effective engagement with public policy stakeholders and the broader community impacted by AI.
Medical Advisors provide medical and scientific expertise and guidance to investigators and CSU (Clinical Study Unit) staff performing clinical trials within a CSU cluster to ensure patient safety and scientific integrity of the protocol which ensures
Are you passionate about improving patient outcomes? Do you have experience in medical affairs and a desire to make a difference in the healthcare industry? We are looking for a Medical Advisor to join our dedicated team
Are you passionate about advancing Microsofts policy agenda and aligning it with the countrys interests? Do you have extensive experience and networks in government, policy, law, communications and/or corporate affairs? Do you want to lead a government
MAIN REPONSIBILITIES / DUTIES JOB POSITION PURPOSE Medical Affairs Scientists (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
Job Description Summary The Japan Program Clinical Head (JPCH) is responsible for clinical program activities for approval and post approval commitment for Re-examination in Japan. The JPCH is responsible for one or more clinical programs across
Position Summary The Director GMT (Genetic & Metabolic Disorders Business Unit) marketing is responsible for driving the development and implementation of the Japan commercial and marketing strategy for HPP, NF1, and LAL-D as well as for
JOB DESCRIPTION: MAIN PURPOSE OF ROLE • Specialist professional individual contributor with comprehensive knowledge in the area of Medical Affairs. • Ability to execute highly complex or specialized projects. • Adapts precedent and may make significant departures
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.
The Mission of Sanofi’s MSL Team and the Medical Science Liaison is to be the trusted scientific partners in the field for external experts and decision-makers engaging in mutual scientific exchanges to accelerate data dissemination. Sanofi’s
Main Responsibilities 製造販売承認取得及び既存製品の維持管理業務 製品の特性やニーズに沿った承認申請戦略の立案 申請戦略及び製造元の原資料に基づく承認申請書の作成 行政当局からの照会に対する回答、社内部署や製造元との連携 法や通知に対する日常的な知識習得及び理解 添付文書、QMS申請、保険適用希望書の作成 販売促進資料の法的要求に関わる確認 製品の変更管理に関する判断 Must Haves 製品知識を習得する学習能力、文章表現能力（日本語及び英語） 英語力（メール、技術文書読解、コミュニケーションレベルでのビジネス実務利用経験） 円滑なコミュニケーション能力、調整力、渉外力、説明能力 論理的思考力、問題解決意識、当事者意識、自立心、向上心 ５年以上の医療機器薬事申請経験又は医療機器開発経験 次のうち1つ以上の経験：①AI又は医療機器ソフトウェアの薬事申請又は開発、②臨床試験付きの製品の薬事申請、③医用電気機器の薬事申請 Nice to Haves 科学的基礎知識（電気、化学、材料工学、ライフサイエンス） 医療機器の設計、品質管理、製造の基礎知識 海外カウンターパートとの業務遂行経験、海外出張経験...
Job Description Purpose Kraft Heinz Northeast Asia (Japan & Korea) is willing to grow business based on our vision “To sustainably grow by delighting more consumers globally”. For sustainable business growth, End-to-End Quality Assurance Program is
Shape your Career with Citi Citi’s Global Legal Affairs and Compliance (GLAC) empowers and protects Citi by providing legal, compliance, investigative, and security services to our firm. We manage compliance risk, provide legal analysis and advice, protect
Work ScheduleStandard (Mon-Fri) Environmental ConditionsOffice Job Description Job title: Regulatory Affairs Manager Thermo Fisher Scientific Inc. is seeking a highly motivated individual to join our world-class team as a Regulatory Affairs Manager in Japan. As a global leader in scientific
Work Flexibility: Hybrid The Jobs Mission Under minimum supervision by Manager and Lead Specialist, he/she understands the laws and regulations, and efficiently conducts the duties such approval applications, notifications and other related tasks. マネジャー、リードスペシャリストの最小の指導の下、薬機法全般に精通し、豊富な知識と経験を有し、円滑な薬事申請及び関連業務の遂行を目的とする。 Key Activities
Are you passionate about driving sustainability initiatives and making a positive impact on the environment and society? Are you ready to lead a team and strategically position our company as a leader in addressing social challenges?
Are you passionate about advancing Microsofts policy agenda and aligning it with the countrys interests? Do you have extensive experience and networks in government, policy, law, communications and/or corporate affairs? Do you want to work for a
Are you experienced in CMC regulatory affairs or in generating high-quality documentation related to drug manufacturing and marketing approval/maintenance? Do you have a strong understanding of CMC requirements in Japan? We are seeking a CMC Expert to join
Key Accountabilities Country Quality System management Lead the implementation and maintenance of GxP quality system with respective operation units, the continues quality system implementation for competencies and related Quality documentation of GxP area: medical, pharmacovigilance, regulatory and
