職位描述
工作性質(zhì)與職責(zé)范圍：
1)Participates in the preparation and execution of regulatory projects necessary to achieve successful registration of company products in order to support affiliate’s business goals and corporate objectives. 參與注冊(cè)項(xiàng)目的籌備和實(shí)施，成功實(shí)現(xiàn)公司產(chǎn)品的注冊(cè)以支持公司的經(jīng)營(yíng)目標(biāo)和企業(yè)目標(biāo)。
2)Assistant to RA director or manager, interactions and negotiations with regulatory bodies (CFDA, CDE, NIFDC etc.,) in China. 協(xié)助注冊(cè)總監(jiān)或經(jīng)理，參與中國(guó)藥品管理部門(mén)的日常交流（國(guó)家食品藥品監(jiān)督管 理局、CDE、 NIFDC等）。
主要職責(zé)
1)Manages, prepares and submits regulatory applications & questions within specified timeline in China. 在規(guī)定的時(shí)間表內(nèi)完成產(chǎn)品的注冊(cè)管理、申請(qǐng)和批準(zhǔn)。
2)Assistant to the regulatory manger, undertakes interactions and negotiations with Regulatory Authorities to secure and optimise regulatory approvals concordant with strategic company goals. 協(xié)助經(jīng)理在產(chǎn)品注冊(cè)過(guò)程中的HA之間的交流，確保與公司戰(zhàn)略目標(biāo)一致，優(yōu)化注冊(cè)的批準(zhǔn)。
3)Plans and prioritizes maintenance activities and regulatory variations to ensure products compliant with China regulatory requirements. 維護(hù)上市產(chǎn)品的生命周期確保滿足中國(guó)法規(guī)要求以及市場(chǎng)需求。
4)Reviews labeling and packaging, promotional and educational material in line with regulatory and company compliance requirements. 審核產(chǎn)品說(shuō)明書(shū)及推廣信息符合國(guó)家及公司合規(guī)要求。
5)Assistant to the regulatory director or manager, provides information to the assigned project planning and regulatory strategic plans in cooperation with global/regional/local staff to achieve and optimize strategic company goals. 協(xié)助注冊(cè)總監(jiān)或經(jīng)理，向當(dāng)?shù)鼗蚩偛咳藛T提供相關(guān)產(chǎn)品信息，以利于制定產(chǎn)品進(jìn)入中國(guó)市場(chǎng)的有競(jìng)爭(zhēng)力的研發(fā)策略。
6)Keeps up-to-date with government legislation relating to regulatory affairs in China. 確保產(chǎn)品信息符合國(guó)家的管理要求以及迅速調(diào)整適應(yīng)法規(guī)變化。
7)Contributes to company systems development, maintain regulatory document management systems.完善產(chǎn)品注冊(cè)檔案及其相關(guān)管理系統(tǒng)。
崗位要求：
Education 學(xué)歷
?University degree in pharmacy, science, biomedical/life science. Higher degree desirable.要求藥劑學(xué)學(xué)士、生物/生命科學(xué)學(xué)士學(xué)位或以上學(xué)歷
Experience經(jīng)驗(yàn)
?more than 3 years regulatory affairs experience in the pharmaceutical field. Experience with Bio/OTC products is desirable. 3年以上處方藥領(lǐng)域產(chǎn)品注冊(cè)事務(wù)經(jīng)驗(yàn)。有 Bio/OTC 產(chǎn)品經(jīng)驗(yàn)者優(yōu)先。
?Experience with new chemical entities (NCE) and/or biopharmaceutical applications, knowledge and understanding of drug development processes. Preferably with a multinational pharmaceutical company. Proficiency with China regulatory affairs processes and regulations. 了解 NCE 和/ 或生物制藥的應(yīng)用和知識(shí)；了解藥品開(kāi)發(fā)流程?？鐕?guó)制藥公司經(jīng)驗(yàn)優(yōu)先；了解中國(guó)注冊(cè)事務(wù)流程法規(guī)要求。
