**此為長期派遣職缺**
**歡迎您將履歷郵寄至Michelle.yu@adecco.com**
Job description of the outsourcing manpower:
- Assist on new product registration, including preparing submission and follow up after submission 協助新產品登記,包括準備送件資料,及送件後所有進度追蹤
- Assist on Product variation, including preparing submission and follow up after submission 協助產品許可證變更,包括準備送件資料,及送件後所有進度追蹤
- Assist on clinical trial, including communication with trial conductor for trial protocol, requesting sample and importation and all relevant administration works 協助臨床試驗,包括與試驗者溝通試驗計畫書內容,樣品申請及進口準備,及相關行政作業
- Support for quality daily operation, including product disposition and return 支援品質相關日常工作,包括產品加工放行、退貨放行
Qualification & Criteria of the outsourcing manpower:
- Bachelor degree in Veterinary Medicine 獸醫學士
- Preference of working experience in laboratory in veterinary medicinal area and knowledge on trial designing for biological products 偏好在獸醫藥品領域的實驗室工作經驗和具備生物製劑試驗設計知識
(At least 1 year working experience in laboratory of veterinary medicinal area)
我們正在尋找一位法規事務助理,負責協助台灣及歐洲市場的法規相關工作。並具備良好的英文溝通能力,能與法規機構(例如:台灣食品藥物管理署 TFDA)進行互動,確保遵守地區性法規要求。
***若具備基本法語能力者將優先考慮***
工作內容:
1. 協助準備並提交台灣及歐洲市場的法規文件及申報資料。
2. 與法規機構(如TFDA)進行溝通,確保遵守適用的法規。
3. 審查並解釋法規要求,確保產品符合當地法規標準。
4. 協助準備法規檔案,包括註冊文件、產品標籤及技術文件。
5. 維護法規數據庫並追蹤申報及審批狀態。
6. 根據需要,進行法規文件和溝通的中英文翻譯。
Qualifications:
Languages:
Fluent in English and Mandarin Chinese (professional written and spoken communication required).
Experience:
Entry-level/junior position. Experience in regulatory affairs or related fields is a plus, but not required.
Skills:
Strong attention to detail, excellent written and verbal communication skills, and the ability to work independently.
Education:
A degree in life sciences, pharmacy, cosmetics, chemistry, microbiology or a related field is preferred but not mandatory.
Other:
Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint) and familiarity with regulatory databases is a plus.
*此職位將涉及與法規機構的直接互動,需確保產品遵循所有相關法規。
1. Managing regulatory authority/IRB applications and approvals
2. Coordinates and executes clinical research activities for assigned products and supports the evaluation of new products
3. Provides technical input to study protocols and assigned studies through all phases of the study process
4.Train and manage study sites and conduct/document study per protocol using GCP guidelines and SOPs
5.Preparation of clinical trial budgets and tracking of expenditure
6. Liaison with CRO responsible for trial-related activities