This is a contractor role untill End of Mar 2025 医薬品,医療機器等の品質,有効性及び安全性の確保等に関する法律(以下,薬機法) 及び関連法規に基 づく,医薬品,医薬部外品の薬事承認申請,⾏政対応,外国製造所との対応等の業務を,業務報告者の監督の下に行う 。 • 医薬品又は医薬部外品の薬事承認申請,届出 • 医薬品又は医薬部外品の変更管理業務(適切なRegulatory Assessmentの実施) • 外部講習会及び関連学会への参加等による薬事•業界知識の向上及び部内への伝達•理系大卒以上 • 5 年以上の CMC 薬事の経験。若しくは CMC 研究または生産部門で 5 年以上の業務経験と, CMC 申請資料作成の経験があり,薬事業務に興味と意欲がある。 •海外カウンターパート及び国内関係部門と連携して業務を遂行する調整能力がある。 •複数の製品の次々に発生する変更事項について,複数の国の変更申請を確実に履行するための,整理•計画•実行能力がある。 •業務上必要な英語の読み書きと会話ができ,さらに上達意欲がある。 ( 目安:
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
Lime is the worlds largest shared electric vehicle company. We’re on a mission to build a future where transportation is shared, affordable and carbon-free. Our electric bikes and scooters have powered 400+ million rides in 250+
Job Purpose and Impact The Industrial Chemical Regulatory Specialist II will ensure compliance with government chemical regulations or standards in the areas of product compliance, hazard communication, customer documentation and other regulatory functions. In this role, you will
SUMMARY Responsible and accountable for Medical Affairs strategy of Urological cancer products C ollaborates with internal and external stakeholders including key opinion leaders to develop and implement the overall M edical Affairs strategy for product lifecycle align ed
Leads and implements the Health Care Compliance (HCC) program locally under supervision of the HCC Officer of MedTech Japan to ensure business practices and activities follow related J&J internal guidelines, local laws and regulations and anti-corruption
職務概要DESCRIPTION: The regular Engineer is responsible for the following duties. 1. NPI / LCM - Technology transfer coordination at site 2. Validation execution (Process and Cleaning Validation) 3. Process improvements execution 4. Standards deployment, PAT, technology
Leads and implements the Health Care Compliance (HCC) program locally under supervision of the HCC Officer of MedTech Japan to ensure business practices and activities follow related J&J internal guidelines, local laws and regulations and anti-corruption
