美時化學製藥股份有限公司
Tiếng Anh Điều kiện
法規(資深)專員 Regulatory Affairs (Sr.) Specialist
11/13 Cập nhật
Toàn thời gian
Mới tốt nghiệp
Tiếng Anh Điều kiệnLương & địa điểm làm việc
Thỏa thuận
(Thường từ 40.000NTD trở lên)
南投縣南投市
Điều kiện
Yêu cầu ngôn ngữ
Tiếng Anh
聽/中等、說/中等、讀/精通、寫/精通
Kinh nghiệm
不拘
Mô tả công việc
1. Review and provide the technical recommendations for CMC documentation and Common Technical Document(CTD) dossier from a regulatory perspective.
2. Interpretation and Handling the regulatory technical query’s responses that were asked by Client and Authority during the due diligence or submission deficiency phase and provide the action plan or solution and scientific justification.
3. Responsible for evaluating the registration feasibility and mapping the global registration strategy for assigned new R&D products.
4. Cooperate and teamwork with R&D, technical, and RA PM on new R&D project technical challenges and complete the dossier till product approval.
5. Responsible for regulatory registration for export products and make sure all the documents are meet the authority's requirements.
6. Responsible for deficiency response preparation to ensure our response meets the authority’s requirements.
7. Accurately follow the update of the registration regulation, and provide the regulation update to the team and training.
Số lượng tuyển dụng
1~1人
Trình độ học vấn
大學(學院)以上
Yêu cầu ngành học
生物學相關、醫學技術及檢驗相關、藥學相關
Giờ làm việc
08:00-17:00
Chế độ nghỉ
週休二日
Loại công việc
Other Legal Professionals
Pharmaceutical Research and Development Staff
Chemical Engineering Research and Development Staff
