Work Flexibility: Hybrid or Onsite Key Areas of Responsibility: Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature
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
職務内容： 以下の業務をRegulatory Expertと共に業務を行います。 ・DMF新規、変更及び維持管理（原薬及び添加剤等）と製販への連絡 ・外国製造業者認定の代理人としての業務 ・体外診断用医薬品/医療機器 承認申請維持管理 ・申請書内容と製造実態との定期的点検 ・PMDA相談 ・GMP適合性調査対応 ・輸入確認（薬監証明） ・法改正動向確認及びグローバル薬事への展開 応募要件： ・薬剤師免許取得 ・日常的な英文メールのやりとりに拒否反応が無いこと。 ・他部署と積極的にコミュニケーションが取れること。 ・医療業界で、薬事申請、品質保証又はCMC経験がある方は歓迎します。...
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
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
MAIN REPONSIBILITIES / DUTIES JOB POSITION PURPOSE The 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 for
MAIN RESPONSIBILITIES / DUTIES JOB POSITION PURPOSE • Act as the Amyloidosis team lead and line manager, leading a team of MAS. Shape the local strategy and ensure the delivery of scientific‑medical expertise and exchange with
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
This is what you will do: This position, Head of Medical Affairs Rare Bone & Endocrine Disorders, Rare Tumours will provide strategic leadership to Alexion’s assigned therapeutic area portfolio, including in-line and pipeline assets. Responsible for providing
Company Description We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North
Basic Purpose of Job Manage case processing activities for Nippon Boehringer Ingelheim’s investigational and marketed products including case submission to Global Patient Safety and Pharmacovigilance (PSPV) and PMDA according to Boehringer Ingelheim (BI)’s internal procedure and
Work ScheduleStandard (Mon-Fri) Environmental ConditionsOffice, Warehouse Job Description Essential Duties and Responsibilities Understand key business drivers and leverage knowledge of the regulatory framework and environment in Japan to propose regulatory solutions that enable the delivery of products and
Job Description Position Overview The Specialist, Quality Systems & Compliance is an individual contributor who supports key GQP Quality Assurance activities on behalf of the Marketing Authorization Holder (MAH). The role plans and executes assigned quality
Job title: Neurology Medical Head Location: Hatsudai, Tokyo About the job The Neurology Medical Head drives clarity and accountability of the entire Japan medical functions and cross-functional team members, to achieve the business objectives through the
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
Medical Affairs Medical Affairs International TTR and Japan stands for integrity through unbiased,objective and balanced medical-scientific dialogs with the medical community. Itplays a strategic role in a matrix of major responsibilities. Summary of Key Responsibilities • Subject matter
MAIN REPONSIBILITIES / DUTIES JOB POSITION PURPOSE The 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 for
Job Description Summary: Innovation is a key pillar in driving Coca-Cola Japan’s strategy for sustainable system growth. The Technical Operations & Commercialization function spearheads innovation projects (including both product and package) end to end from concept
About the job As Medical Quality Excellence within our Medical Affairs team, youll play a pivotal role in upholding ethical standards, compliance, and quality across our medical operations — helping shape a transparent and high-performing medical organization.
Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a