醫藥/醫療器材/化妝品領域都是我們正在找尋的人才喔 ~
1.負責彙總、解讀藥物註冊法規、技術要求(包含但不限於TFDA、FDA法規、ICH指南),並為公司研發提供合規指導和風險管理;
2.準備原始IND、修改和補充,包括與其他部門對接以獲得必要的組件和草稿報告和敘述組件
3.了解藥品的生命週期和基本的GMP工作流程
4.積極參與監管報送流程及參與產品開發週期的風險評估
5.跟進公司在研專案分配與協調,跟進註冊專案進度,及時發現和處理註冊專案進程中的問題,確保完成註冊任務;
6.協調和處理註冊評審過程中的相關問題;
7.及時掌握藥品註冊政策的變化情況,對研發人員進行培訓和管理。
1. To prepare timely original IND, amendments, and supplements, including interfacing with other departments to obtain the necessary components and drafts reports and narrative components
2. Understanding of the lifecycle of drug products and basic GMP workflow
3. Actively involved in the regulatory submission process
4. Involve in the risk assessment during product development cycle
※彈性上班8:00~10:00(滿八小時之彈性下班)
~依學歷、經歷敍薪資,具醫療產業經驗~
~必備英文溝通順暢流利~
1. 分子診斷產品開發:市場調查、規格制訂、時程控管、產品行銷策略及國內外行銷活動。
Lead molecular diagnostics product development including market research, product specification development, timeline management and both domestic and international marketing activities
2. 分子診斷委託開發暨製造服務(CDMO)專案管理。
Project management for contract development and manufacturing organization (CDMO) services
3. 內外部產品教育訓練、服務方案解說及展示。
Internal and external product training
4. 遵循品質管理體系,即時處理客戶詢問、抱怨、產品保固、版本更新等問題
Follow the quality management system to promptly address customer inquiries, complaints, warranty, and version update issues.
5. 整合分析產品問題及導入改善對策。
Analysis of product issues and develop improvement plans