崗位職責:
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、負責藥學相關申報資料撰寫和修訂;
2、按照申報要求,完成各專業(yè)申報資料審核;
3、協(xié)助完成各個國際法規(guī)市場申報提交和溝通;
4、負責跟進國際注冊相關指南和法規(guī)政策,參與藥品往冊相關法規(guī)的解讀、培訓,參與各項申報策略相關調(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/監(jiān)管科學或其他相關專業(yè);
2、較強的外語能力,英語口語流利,能熟練進行溝通;
3、有3年以上在生物企業(yè)工作經(jīng)驗,從事過生物產(chǎn)品研發(fā)相關技術工作(如純化、分析等,了解非臨床和臨床研究),負責或參與過項目的國際申報者優(yōu)先(社招);
4、有良好的溝通和人際交流能力,有較強的文字表達能力。