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400-885-9898
更新于 10月15日
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藥品注冊(cè)主管

1.2-1.5萬(wàn)·13薪

職位描述

生物制品
Job Description :
1. Report to: RA Manager
2. Responsible for communication with India RA team about current NMPA/CDE regulations and guidelines.
3. Responsible for collection of the required technical dossiers from India RA team of import drugs (Dosage formulation)
for new IDL filing, IDL renewal filing, variation filing, and responses to CDE query, etc
4. Responsible for preparation of module 2 and overview information (dossier No. 1-8).
5. Responsible for translation(English to Chinese ),Finalization and submission of the registration dossiers of import drugs (Dosage formulation and API ) for new IDL filing, IDL renewal filing, variation filing, responses to CDE query and coastal testing, etc.
6. Responsible for communication with the authorities including but not limit to NMPA, CDE, NIFDC, port IDC, etc, to ensure smooth of the registration/coastal testing progress.
7. Finish the other RA related jobs assigned by RA head.
Position qualifications:
1. Degree in Scientific/Biochemistry/Pharmacy
2. At least5 years'working experience in regulatory affairs, especially for the registration experience of biologic drugs is preferred.
3. Familiar with the 《National Regulation of Drug Registration》 and latest 《Drug administration laws and regulations》
4. Familiar with various guiding principles as well as local/regional regulatory processes and changes that are implemented or being considered.
5. Direct experience for new IDL filing, IDL renewal filing, variation filing.
6. Fluent spoken and written English.

職位發(fā)布者

郭女士/人事

立即溝通
公司Logo盛發(fā)藥業(yè)(上海)有限公司
總公司印度太陽(yáng)藥業(yè)有限公司（Sunpharma）成立于1983年，是一家在印度股票市值排名第一的跨國(guó)制藥企業(yè)，主要生產(chǎn)?？扑幤芳捌湓纤?。我們的處方藥制劑主要涉及心血管、中樞神經(jīng)、消化、呼吸等領(lǐng)域以及糖尿病等慢性疾病的治療。我們?cè)谒孀愕母鱾€(gè)治療領(lǐng)域均處于領(lǐng)先地位，銷售網(wǎng)絡(luò)覆蓋全球主要市場(chǎng)，包括在美國(guó)、歐洲、東南亞、俄羅斯、中東、拉丁美洲、非洲及亞洲等重要的國(guó)際市場(chǎng)，其中超過(guò)50%的銷售來(lái)自于歐美市場(chǎng)。2012和2014年，太陽(yáng)藥業(yè)被福布斯（Forbes Global）評(píng)選為全球百?gòu)?qiáng)最具創(chuàng)新力公司。盛發(fā)藥業(yè)（上海）有限公司是全資子公司，于2020年12月底成立，取代之前的代表處，更好的服務(wù)于中國(guó)市場(chǎng)。
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