Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive
職位記述書 職務名 薬事規制スタッフ 勤務地 東京本社 レポート先 Quality, Safety & Regulatory Manager 担当ディビジョン Consumer Beauty & Luxury /Rimmel, Gucci, Burberry, CK, Tiffany,etc. 雇用形態 正社員 (full time) 業務内容 化粧品製造販売業者コティジャパンの薬事業務の遂行 主要業務 (70%) コティジャパン薬事規制業務 マーケティングおよび R&D と協力し、製品の成分、製品訴求、および製品表示が日本の規制に適合している事の確認 化粧品の申請書類作成・申請業務 化粧品の届出業務 (30%) 安全管理責任者（安責）業務
職務の目的 開発品目の承認申請時の添付文書案作成等： 薬事規制及びGSKポリシーに従い、申請内容に基づく添付文書案作成においてプロジェクトチームをリードする。 CCDSに基づく添付文書の記載事項が承認されるよう、承認審査における添付文書関連照会事項に対する回答作成をリードする。 市販品目の添付文書管理： 薬事規制及びGSKポリシーに従い、最新の情報に基づく添付文書の改訂及び改訂添付文書の公開を滞りなく行う。 添付文書に係るカスタマーからの問い合わせに対して適切に回答する。 アートワーク管理： 必要な薬事Inputを行い、アートワークの変更及び製品への封入切り替えが滞りなく行われるように取り計らう。 市販後薬事： 市販品目のライフサイクルマネジメント（主にCMCの変更管理）に関連し、規制当局及び社内関連部署と良好な関係を築き、規制当局との窓口業務を適切に遂行する。 主な業務内容 承認申請資料（添付文書案含む）の作成・改訂 承認申請時の添付文書案作成における取りまとめ 承認審査時の添付文書関連照会事項に対する回答作成 添付文書改訂相談における当局窓口 添付文書改訂版の校正 添付文書の届出 PMDA 公開サイトの企業ページ管理・必要情報の登録・公開 添付文書に係る外部問合せに対する回答 患者向医薬品ガイドの作成・改訂、当局への改訂相談、公開 市販品目の変更管理に関する薬事業務 業許可管理の業務 当局対応での、承認時期への影響や承認後のグローバルビジネス及び国内での市販製品の供給への影響等を鑑みた方針決定 業界団体・学術団体等を通じた薬制に関する規制調和の推進 ライフサイクルマネジメントに関連する市販後薬事の業務全般におけるタイムライン管理、薬事的課題の把握及び解決策の提案、当局交渉等のマネジメント 必要な条件 医薬品開発、薬事関連業務、変更管理業務あるいは安全性管理業務の経験 海外とメール又は口頭でコミュニケーションができる英語力 当局関係者と交渉するためのコミュニケーション能力 基本的なITスキル（Word, Excel, Power Point等） 向上心があり、変革に対して前向きであること
職種 正社員 職務明細 Tokyo-based Langley Esquire is a public affairs consulting firm specializing in government relations, strategic communications, and public policy. We overcome challenges at the nexus of government, industry, and society. With over 30 years of
職種 インターンシップ 職務明細 Tokyo-based Langley Esquire is the premier public affairs consultancy dedicated to solving issues in Japan’s unique regulatory environment. We overcome unprecedented challenges at the nexus of government, business, and society. With over 30 years of
職種 正社員 職務明細 Inspiring Change, Shaping the Future. At Gemini Group, we believe in the power of civic engagement to transform society. Our mission is to drive meaningful, positive change in Japan by influencing public policy,
This is what you will do: Associate Director, Regulatory Affairs is responsible for overall pharmaceutical affairs associated with obtaining pharmaceutical product approval. The duties include complying with Japan pharmaceutical affairs act, developing good relations with the regulatory authority, and performing pharmaceutical
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.
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
Work Schedule Other Environmental Conditions Office Job Description バイオサイエンス事業部 製品の商業利用に関連する事業開発マネージャーをお任せします。 1. バイオサイエンス事業部製品カテゴリー PCA (Protein and Cell Analysis) タンパク・抗体・細胞分析用試薬等 PCA_1, PCA_2 Molecular biology 分子生物学研究用試薬 Molecular biology_1 Moldcular biology_2 Sample Prep サンプル精製用試薬 Sample Prep Cell biology 細胞生物学研究用試薬 Cellbiology 業務内容
Job Description When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected,
Job Description Job Summary: To ensure that clinical supplies are stored and distributed in accordance with Fisher Clinical Services (FCS) approved procedures and policies, cGMP, cGDP, and regulatory requirements. Maintain the FCS Japan Quality System in compliance
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied
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
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied
Are you a detail-oriented finance professional with experience in financial and accounting operations? Are you an experienced Finance Manager looking for a new challenge? Novo Nordisk is seeking a talented Finance Manager to join our Finance
We are Reckitt そのチカラを自由に使え。 今の自分を超えていけ。 FREE YOUR POWER. PROGRESS YOURSELF. Home to the worlds best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the
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+
Managing Director, Tokyo As Teneo continues to grow their operations across Asia Pacific, Teneo is looking for a high calibre candidate to join our Tokyo office as a Managing Director and lead client strategy and commercial
We are looking for a solution consultant to join our Life Science & Healthcare solution consulting team in Tokyo. We are a team of product experts and is responsible for growing revenue from both existing and
