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5-7年经验 -
硕士 -
招1人 -
11-09 发布
职位描述
职位描述： JD:1.Project management skills including registration planning with team leader2.Prepare and filing of registration dossiers; Filing of new drug/device application; Prepare product labeling according to FDA requirements.3.Follow up registration procedure; Handle technical queries from FDA.4.Follow up testing in local institute or NICP.5.Maintain close relationship with officers in Health Authority (FDA).6.Be tactful in making adjustments to facilitate the process7.Get final registration permits.Working capacity:At least 5 years related working experience in regulatory affairs for pharmaceuticals.Working experience with multinational company will be top priority.Knowledge of medical device & pharmaceutical regulationGood commend in EnglishExcellent communication skills and team spiritsQuick learner and self-motivatedBe able to work in new developmental area 职能类别： 药品注册
联系方式
江苏省泰州市中国医药城药城大道一号陶弘景路8号双子楼1210室
公司信息
泰州越洋医药开发有限公司www.overseaspharm.com于2011年12月成立于江苏省中国（泰州）医药高新区。公司由“国家千人计划特聘专家”闻晓光博士创立，研发团队核心成员及其美国合作伙伴曾就职于GSK、Pfizer、Teva、Johnson等跨国药物公司，拥有先进的药物开发理念和成功的缓控释制剂产品开发经验。 越洋医药是一个特色技术平台公司，主要从事缓控释平台技术建设及缓控释新药(505（B）(2)-NDA)和仿制药产品(505（j)-ANDA)的开发。公司的产品定位于中美两国市场/中美欧三个地区市场，实现中国由原料药出口向制剂产品出口转型升级，实现高端制剂国产化，高额利润本土化。为患者提供新药以满足还未满足的临床需求。越洋关爱人类健康，世界关注越洋技术。
