Japanの求人
最終更新日: 4日前
Associate Director or Director of Regulatory Compliance
BeiGeneJapan Local Representative for Regulatory Affairs, Local Compliance.Provide leadership and strategic direction for Regulatory Affairs and Compliance Communication in Japan, primarily in the post-marketin...もっと見せる最終更新日: 30日以上前
Project Manager - Solar & BESS
Bradman Carbon & Renewable EnergyJP Tokyo based with trips to site.Local company, part of an International funds manager.Experienced, competent senior management.
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アパレル販売スタッフ ※全国募集※
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Team Manager, Customer Service
Amazon Japan G.K.JP Community Shopping Moderate チームマネージャーを募集しています。アマゾンカスタマーサービスはカスタマーサービスチームマネージャーの役割と責任範囲を次のように定義しています。.Customer Obsessionのロールモデル、カスタマーサービスのカルチャーの実践者および専門家、チームの育成者、そしてアマゾン企業文化の推進者として機能します。従業員の育成とサポートに...もっと見せる最終更新日: 30日以上前
【ERP導入コンサルタント】ハイブリッド勤務航空宇宙産業向けITソリューション
Daijob日本 Tsunami Tsolutions は2003年の創業以来、航空宇宙産業に特化した最先端ITソリューションを提供してきたリーディングカンパニーです。大手OEMメーカーからスタートアップまで、あらゆる規模のクライアントと共に成長してきました。.
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EPC Technical Sales Specialist
Bradman RecruitmentJP Major Japanese / International Renewable Energy Developer, EPC & IPP.Business Level English, Japanese N1 or higher, required.
Tokyo based / Hybrid role with considerable flexibility & benefits.T...もっと見せる最終更新日: 30日以上前
介護サポートスタッフ【アルバイト・パート】
（株）やさしい手 渋谷東訪問介護事業所日本 HPやサービス提供責任者ケアマネジャー、エリアマネージャーになる方も多数。.もっと見せる最終更新日: 30日以上前
On-Site Support Consultant
Amaris ConsultingJapan Join our team and start a new adventure in an international and dynamic environment where you will be able to fulfil your career expectations in a fast-growing organization.You will ensure smooth o...もっと見せる最終更新日: 13日前
この求人はお住まいの国からは応募できません。
Associate Director or Director of Regulatory Compliance
BeiGeneJapan30+日前
職務内容の詳細Ability to work independently and effectively handle multiple priorities in a fast-paced environment Excellent interpersonal skills, strong organizational skills and effective written and verbal communication skills across all levels within an organization Scientific background Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook Market competitive compensation package including performance-based annual bonus scheme Company shares (generous welcome grant and performance-based annual equity plan!) In-house and external learning and development opportunities Fantastic benefits program and keep improving! Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear : Cancer has no borders and neither do we. Join us and Make momentum in your career! Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking / Data Analysis Financial Excellence Communicates with Clarity
Job Description :
General Description :
- Local Representative for Regulatory Affairs, Local Compliance
- Provide leadership and strategic direction for Regulatory Affairs and Compliance Communication in Japan, primarily in the post-marketing phase, with proactive input into commercial regulatory requirements during development.
- Act as an internal consultant on pharmaceutical regulations, including the PMD Act.
- Collect, analyze, and implement domestic pharmaceutical regulations; monitor and share regulatory trends (e.g., ICH, PIC / S, MHLW / PMDA).
- Promote regulatory awareness through internal briefings and materials on PMDA / MHLW updates and guidelines.
- Establish and maintain regulatory compliance systems, including SOPs, internal audits, and governance support.
- Oversee business license management (e.g., MAH, manufacturer) and collaborate with GQP / GVP departments.
- Package Insert (labeling) maintenance for commercial products
- Support the Three Key Roles under the PMD Act (General Marketing, Safety, and Quality Compliance Officers).
- Lead and prepare for inspections by regulatory authorities, including the Tokyo Metropolitan Government.
- Manage GMP inspections (pre-approval, periodic) and foreign manufacturer accreditation with CMC Regulatory and Quality.
- Handle PMDA / MHLW interactions for commercial products, including consultations, inquiries, and GMP / CMC variation responses.
- Lead and coordinate CMC variation submissions with global and local CMC Regulatory teams.
- Collaborate with global regulatory counterparts to align regional and global strategies.
- Coordinate with internal teams (e.g., Development, QA, Safety, Manufacturing, Marketing, Medical Affairs) and external stakeholders (e.g., industry associations, academic societies).
- Support Japan-specific regulatory requirements such as RMPs, re-examination applications, and post-marketing surveillance.
- Maintain package inserts and review promotional materials for regulatory compliance.
Qualification Required :
Education Required :
Bachelor degree and / or Master Degree in Pharmacy or life science.
Other Qualifications :
Computer Skills :
Travel : up to 10%
What We Offer To Our Valued Employees
BeOne Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
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