Regulatory Affairs

缔脉生物医药科技(上海)有限公司

浦东新区-张江镇 | 1年工作经验 | 硕士

2020-05-20发布

招聘人数:若干

100000-250000元/年

申请职位

职位信息

Responsibilities: - Responsible for the regulatory affairs, submissions support for dMed and its clients, implementing drug registration operation service support as per project needs, such as IND, NDA, lifecycle submissions and healthy authority query response, as well as the submissions-related activity. - Maintain good relationship with regulatory authorities for business support. Keep apprised of regulatory developments and understanding key regulatory changes locally and globally. - Contributing to dMed internal regulatory intelligence development, documentation system and training program, supporting business opportunities, etc. Competency Requirements: - Bachelor or master degree in a life or medical sciences or relevant scientific background. - Thorough knowledge of ICH Guidelines, local regulations and GXPs including, but not limited in regulatory requirements for the conduct of clinical development programs. - Effective project management skill. - Superb organization, communication s skills (oral and written in Chinese & English) and strong interpersonal skills to be able to effectively interact with customers, key stakeholders, health authorities, multidisciplinary groups as well as with vendors. - Good analytical and issue identification abilities, and attention to detail 6. Good teamwork spirit and positive working attitude. 备注: ‘职位月薪’ 仅供参考,具体薪资和福利将根据候选人经验和能力综合评定。

联系方式

上班地址:上海市浦东新区祥科路298号佑越国际3楼301-305

缔脉生物医药科技(上海)有限公司


•民营公司

• 少于50人

• 制药/生物工程

缔脉生物医药科技(上海)有限公司是一家临床合同研究组织(CRO),旨在为中国及全球生物医药公司和医疗器械公司提供高水准全方位的服务,以我们专业能力、全球经验、先进技术和创新方法确保临床试验符合科学规范和满足法规和监管要求。我们希望推动国内临床开发水平和技能的不断提升从而促进中国创新药物走向全球,同时我们也希望以创新致力于提高临床试验的规划和执行效率,从而最终增大客户药物和医疗器械的成功几率。缔脉聚集了大批具有国际视野的、在临床试验方面具有丰富经验的专业人才,我们的主营业务包括专家咨询、临床试验运营、生物统计与编程、数据管理、药物安全与警戒、临床科学与医学事务、质量保证、稽查及核查准备、法规事务和策略等。
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