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
About ERM ERMは、世界最大級のサステナビリティ専門コンサルティングファームとして、世界有数の企業とパートナーシップを構築し、サステナビリティ課題に対する革新的なソリューションの提供と、将来世代の機会を守りながら現在のニーズを満たす持続可能なビジネス機会の創出を支援しています。 当社には、40以上の国・地域、150以上の拠点に8,000名を超える専門家が在籍しており、戦略的変革と技術的実行力を融合することで、クライアントのサステナビリティの実装を迅速かつ大規模に推進しています。 この取り組みを、ERMでは「Boots to Boardroom」アプローチと呼んでおり、戦略立案から現場での実行まで一貫して支援する包括的なサービスモデルを提供しています。 現在、日本におけるSustainable Product & Supply Chainチームの事業拡大に伴い、コンサルタントを募集しています。 業務内容 本ポジションでは、国内外のクライアントに対し、化学物質規制に関するコンサルティングサービスを提供いただきます。 主な業務内容は以下の通りです： コンプライアンスレビューおよび関連文書の管理 サプライヤー、輸入業者、当局などの第三者との調整業務（クライアント代理） 化学物質規制に関する専門的アドバイスの提供 応募要件 日本化審法（CSCL）および安衛法をはじめ、Korea-REACH、China-REACH、Taiwan-REACH、EU-REACH、米国TSCAなどに基づく新規または既存化学物質の登録業務経験5年以上 日本語ネイティブレベル・および英語での高いコミュニケーション能力 加えて、主体的に行動できる方、適切な判断力を持ち、ステークホルダーとの関係構築および円滑な協働ができる方を歓迎します。 化学、法務、または関連分野での実務経験をお持ちの方は尚可です。 求める人物像 本ポジションでご活躍いただくためには、以下のスキル・特性が求められます： クライアント志向の高い姿勢 優れたコミュニケーション能力（口頭・文書） グローバルな化学物質規制に関する知識 日本語および英語によるビジネスレベルの対応力 About ERM ERM is the world’s largest
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
JOB DESCRIPTION: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you
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
JOB DESCRIPTION: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you
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