職位概述 Job Summary :
Ensure locally launched MD/IVD products under the name of RDTW are complied with relevant regulations, including but not limited to product registrations and review of promotional materials. 確保以RDTW名義在本地上市的MD/IVD產品符合相關規定,包括但不限於產品註冊和宣傳材料審查。
Engage and maintain the good and close relationship with TFDA and other internal & external key stakeholders.與 TFDA 和其他內部和外部主要利益相關者保持良好和密切的關係。
Monitor and analyze key regulatory policy trends and translate into predictive insights to support management of product launch and during product lifecycle. Assist line manager to handle tasks and projects as necessary. 監控和分析關鍵的法規政策趨勢,並將其轉化為預測見解以支持產品上市和產品生命週期的管理。
主要工作職責 Main Tasks & Responsibilities :
Act as the regulatory point of contact for global/regional product launch projects in planning and managing local submission projects with the alignment on local launch plan.
作為全球/區域產品上市項目的法規聯絡窗口,規劃和管理本地查驗登記專案以與本地上市計劃保持一致。
Make concrete registration plan for new and conversion products and provide strategic advices to management;
為新產品和轉換產品製定具體的查驗登記計劃,並為管理層提供戰略建議。
Ensure that company's products comply with Taiwan FDA issued regulations and registration requirements, including but not limited to:
確保公司產品符合台灣FDA的相關法規要求,包含但不限於:
Others 其他事項:
主要工作許可權 Power Reserved
Observance and adherence to regulations and other contents stated in the prevailing Standard Operating Procedures and Delegation of Authority Manual 遵守現行標準作業程序和授權委託程序中規定的法規和其他內容
基本任職資格 Basic Requirements of the Job :
教育背景 Education :
Bachelor degree or above, subject in medical laboratory/engineering, pharmaceuticals or Science related fields.
大學本科以上學歷,醫學檢驗/工程、製藥或理科相關專業。
工作經驗與專業知識/技能 Experience & Skills:
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.
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