職位描述
工作性質與職責范圍：
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. 參與注冊項目的籌備和實施，成功實現公司產品的注冊以支持公司的經營目標和企業目標。
2)Assistant to RA director or manager, interactions and negotiations with regulatory bodies (CFDA, CDE, NIFDC etc.,) in China. 協助注冊總監或經理，參與中國藥品管理部門的日常交流（國家食品藥品監督管 理局、CDE、 NIFDC等）。
主要職責
1)Manages, prepares and submits regulatory applications & questions within specified timeline in China. 在規定的時間表內完成產品的注冊管理、申請和批準。
2)Assistant to the regulatory manger, undertakes interactions and negotiations with Regulatory Authorities to secure and optimise regulatory approvals concordant with strategic company goals. 協助經理在產品注冊過程中的HA之間的交流，確保與公司戰略目標一致，優化注冊的批準。
3)Plans and prioritizes maintenance activities and regulatory variations to ensure products compliant with China regulatory requirements. 維護上市產品的生命周期確保滿足中國法規要求以及市場需求。
4)Reviews labeling and packaging, promotional and educational material in line with regulatory and company compliance requirements. 審核產品說明書及推廣信息符合國家及公司合規要求。
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. 協助注冊總監或經理，向當地或總部人員提供相關產品信息，以利于制定產品進入中國市場的有競爭力的研發策略。
6)Keeps up-to-date with government legislation relating to regulatory affairs in China. 確保產品信息符合國家的管理要求以及迅速調整適應法規變化。
7)Contributes to company systems development, maintain regulatory document management systems.完善產品注冊檔案及其相關管理系統。
崗位要求：
Education 學歷
?University degree in pharmacy, science, biomedical/life science. Higher degree desirable.要求藥劑學學士、生物/生命科學學士學位或以上學歷
Experience經驗
?more than 3 years regulatory affairs experience in the pharmaceutical field. Experience with Bio/OTC products is desirable. 3年以上處方藥領域產品注冊事務經驗。有 Bio/OTC 產品經驗者優先。
?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/ 或生物制藥的應用和知識；了解藥品開發流程。跨國制藥公司經驗優先；了解中國注冊事務流程法規要求。
