Position Responsibilities
崗位職責
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廠緊密聯(lián)系,負責進口產品的文件分析、注冊、再注冊、變更注冊文件的準備和提交。
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.
跟蹤注冊進度,根據(jù)官方及公司內部需要實施注冊活動(包括問題回復、樣品清關、質量復核試驗、GMO申請、標簽確認等), 并負責所有的生物制品產品維護。
3. Maintain good contact with officials, CROs and other partners.
與政府、試驗機構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.
不斷更新注冊法規(guī)及相關知識,識別并報告其對公司的有關影響。及時更新注冊政策的變化,并向公司匯報可能的影響。
5. Assist to perform other RA related task.
協(xié)助其他注冊相關工作。
Job Requirements
崗位要求
1. Bachelor or above degree in biological, veterinary, or in life science related course.
本科及以上學歷,生物制品、獸醫(yī)或生命科學教育背景。
2. Minimum 3 year experience in biological product registration.
至少3年以上生物制品注冊經驗。
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:五險一金、帶薪年假、補充醫(yī)療保險、定期體檢、周末雙休、交通補助、采暖補貼