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1. Closely work with corporate and different campuses, responsible for dossier analysis and preparing regulatory submission of import product, renewal, variations registration. 與公司總部及不同生產(chǎn)廠緊密聯(lián)系，負(fù)責(zé)進(jìn)口產(chǎn)品的文件分析、注冊(cè)、再注冊(cè)、變更注冊(cè)文件的準(zhǔn)備和提交。 2. Follow-up the registration progress, conduct regulatory activities according to the need of authority and intercompany (including response to queries, samples import clearance, quality compliance test, GMO application, labeling etc.), and keep maintenance of the portfolio. 跟蹤注冊(cè)進(jìn)度，根據(jù)官方及公司內(nèi)部需要實(shí)施注冊(cè)活動(dòng)（包括問(wèn)題回復(fù)、樣品清關(guān)、質(zhì)量復(fù)核試驗(yàn)、GMO申請(qǐng)、標(biāo)簽確認(rèn)等）， 并負(fù)責(zé)所有的生物制品產(chǎn)品維護(hù)。 3. Maintain good contact with officials, CROs and other partners. 與政府、試驗(yàn)機(jī)構(gòu)及其他合作伙伴等維持良好聯(lián)系。 4. Keep update on changing regulatory requirements and knowledge, identify and report their related impact on company. 不斷更新注冊(cè)法規(guī)及相關(guān)知識(shí)，識(shí)別并報(bào)告其對(duì)公司的有關(guān)影響。及時(shí)更新注冊(cè)政策的變化，并向公司匯報(bào)可能的影響。 5. Assist to perform other RA related task. 協(xié)助其他注冊(cè)相關(guān)工作。

Job Requirements 崗位要求

1. Bachelor or above degree in biological, veterinary, or in life science related course. 本科及以上學(xué)歷，生物制品、獸醫(yī)或生命科學(xué)教育背景。 2. Minimum 3 year experience in biological product registration. 至少3年以上生物制品注冊(cè)經(jīng)驗(yàn)。 3. Good English skills both in written and spoken. 英文流利。 4. Good interpersonal communication skills. 良好的人際溝通能力。

職位福利：五險(xiǎn)一金、帶薪年假、補(bǔ)充醫(yī)療保險(xiǎn)、定期體檢、周末雙休、交通補(bǔ)助、采暖補(bǔ)貼