首页 职位描述

药品注册

缔脉生物医药科技(上海)有限公司

北京市-朝阳区 | 5-7年工作经验 | 本科

2020-10-17发布

招聘人数:1人

100000-300000元/年

申请职位

职位信息

Key Responsibilities - Ensure required regulatory support for dMed and its clients, implement drug registration strategy plan or operational service as per project and/or customer’s needs 1.Provide regulatory related guidance and service regarding design, development, evaluation or marketing of the product to the project teams to ensure compliant with relevant guidelines and governmental regulations. 2.Work with clients, internal teams and key stakeholders for preliminary registration planning based on drug’s nature, clinical indication, intended clinical trial regime, data from previous studies, and the jurisdiction(s) the sponsor intends to submit. 3.Track and monitor the implementation process: all the way through IND/CTA/NDA submissions. Review of exception and needs of customer and follow up with customer per projects. 4.Lead or Support the development or implementation of clinical trial protocols, preparation and submission of regulatory agency applications, dossier, or correspondence per project and business needs. 5.Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced. 6.Review regulatory agency submission materials, marketing literature or user manuals, etc. per project needs to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards 7.Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats; Or evaluate new software publishing systems and confer with regulatory agencies concerning news or updates related to electronic publishing of submissions. - Establish and maintain good relationship with regulatory authorities and industry associations for business support and understand key regulatory changes 1.Monitor changes of industry related regulations, support to develop and implement regulatory strategy for the responsible projects or provide needed consultation 2.Maintain Health Authority and industry association interaction on behalf of dMed for regulatory strategy assessment, have updated knowledge and understanding on regulatory changes and trends, enhance dMed exposure and contribution. - Contribute to dMed internal regulatory intelligence development, documentation system and training program, consultation and support to business opportunities, etc. 1.Establish and maintain internal regulatory intelligence pool as necessary; Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes. 2.Communicate regulatory information to the company and relevant departments or clients, and ensure that information is interpreted correctly. 3.Establish and ensure operational process, training programs, and systems are appropriately and effectively support compliance to regulatory requirements changes as well as applicable quality standards. 4.Support activities such as audits, regulatory inspections, etc. 5.Develop, update and maintain regulatory affairs relevant SOPs, ensure SOPs training completion; Maintain accurate documentation of SOPs and other training files. Requirements - Bachelor or master degree in a life or medical sciences or relevant scientific background. - At least 5 years of relevant pharmaceutical industry experience, and prior regulatory affair or submission related work experience with understanding of GXP requirements and solid knowledge of ICH guidelines. - Experience in supporting new product plan, registration trials, regulatory interactions will be a plus. 备注: ‘职位年薪’ 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:北京朝阳,霞光里15号楼, 霄云中心23楼B座2302、2303、2305室

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。
查看该公司所有职位