崗位職責(zé):
1、Write and revise application dossiers of CMC
(chemistry,manufacturing and control)discipline.
2、Review application dossiers of all disciplines inaccordance with regulatory requirements.
3、Assist in application submitting and communicating of various international regulatory markets.
4、Follow up international regulations,guidelines and policies;participate in the interpretation and training of related regulations,and research work of submission strategies.
1、負(fù)責(zé)藥學(xué)相關(guān)申報(bào)資料撰寫(xiě)和修訂;
2、按照申報(bào)要求,完成各專業(yè)申報(bào)資料審核;
3、協(xié)助完成各個(gè)國(guó)際法規(guī)市場(chǎng)申報(bào)提交和溝通;
4、負(fù)責(zé)跟進(jìn)國(guó)際注冊(cè)相關(guān)指南和法規(guī)政策,參與藥品往冊(cè)相關(guān)法規(guī)的解讀、培訓(xùn),參與各項(xiàng)申報(bào)策略相關(guān)調(diào)研工作。
任職要求:
1、Master
s degree or higher,majoring in Biological/Pharmaceutical/Regulatory Science or relatedfields.
2、Strong foreign language skills,fluent in spoken English,able to comicate conpetently.
3、More than 3 years of Work experience of bio-techmedicinal product R&D in pharmaceutical companies(e.g.purification,analysis etc.,uderstanding ofnonclinical and clinical research).Experience of being responsible for or involved in international application submission is preferred.(Social Recruitment)
4、Good communication and interpersonal skills,and strong writing skills.
1、碩士及以上
生物/藥學(xué)/監(jiān)管科學(xué)或其他相關(guān)專業(yè);
2、較強(qiáng)的外語(yǔ)能力,英語(yǔ)口語(yǔ)流利,能熟練進(jìn)行溝通;
3、有3年以上在生物企業(yè)工作經(jīng)驗(yàn),從事過(guò)生物產(chǎn)品研發(fā)相關(guān)技術(shù)工作(如純化、分析等,了解非臨床和臨床研究),負(fù)責(zé)或參與過(guò)項(xiàng)目的國(guó)際申報(bào)者優(yōu)先(社招);
4、有良好的溝通和人際交流能力,有較強(qiáng)的文字表達(dá)能力。