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。跨國(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。
