職位描述
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職責:o 制定和管理項目注冊工作,著重于制定注冊項目計劃和開展具體的注冊工作。Develop and manage project registration activities focused on the development of registration project plan and execution of detailed registration activities.o 準備注冊資料和技術要求文件。Prepare registration dossier and technical requirement document.o 與項目團隊密切合作,以確保注冊工作按照項目時間表進行。Work closely with project team to ensure registration activities meeting project timeline.o 與直線經理共同為法規(guī)事務部和跨職能項目團隊成員確定項目或項目的優(yōu)先級。Define priorities together with line manager on assigned projects or across multiple projects, for RA and cross functional project team members.o 支持內部/外部審計。為團隊提供法規(guī)指導。Support the internal/external audit. Provide regulatory guidance to team.o 與內部合作伙伴保持良好關系。與這些職能部門合作伙伴有效地溝通。Maintain the relationships with internal partners. Effectively communicate with these functional partners.o 鑒別、評估并專業(yè)解讀新政策與法規(guī),以支持產品開發(fā)和注冊。Identify, evaluate and professionally interpret new policies and regulations for product development and registration.o 提供法規(guī)和政策走向方面的咨詢與說明。Provide consultation and direction regarding regulation and policy trends.o 積極參與到國行標制修訂的相關活動中,支持強生項目和業(yè)務。Actively participant in the creation and revision of GB/YY standard, to support J
工作地點
地址:北京朝陽區(qū)北京-朝陽區(qū)
求職提示:用人單位發(fā)布虛假招聘信息,或以任何名義向求職者收取財物(如體檢費、置裝費、押金、服裝費、培訓費、身份證、畢業(yè)證等),均涉嫌違法,請求職者務必提高警惕。
職位發(fā)布者
Nora..HR
強生(上海)醫(yī)療器材有限公司
- 醫(yī)療設備·器械
- 1000人以上
- 外商獨資·外企辦事處
- 廈門心血管病醫(yī)院