Manager, Regulatory Affairs 北京

月薪： 2.5-3万/月

该公司所有职位
  • 无工作经验
  • 招1人
  • 英语熟练
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 补充公积金
  • 员工旅游
  • 专业培训
  • 出国机会
  • 绩效奖金
  • 年终奖金
  • 弹性工作
  • 定期体检

职位描述

职位描述： *Job Description1. Provide technical support to team members of Regulatory Affairs Department to ensure that they have the required knowledge to fulfill their duties, including training.2. Provide overall supervision and guidance for Regulatory Affairs3. Support for administrative works of Regulatory Affairs4. Participate in and contribute to project bids, including client presentations.5. Support the feasibility evaluation process from Regulatory Point of View.6. Regulatory consultation7. Regulatory compliance review/evaluation and gap analysis, including label, common technical documents, study report, and etc.8. Regulatory information collection and sharing9. Regulatory and IRB-related submission and coordination, including initial submission, supplementary submission, amendment application and etc.10. Archiving documents management if designated as an archivistIf designated as clinical trial submission coordinatorMay be to perform the role of a Regulatory Lead in certain projects. When acting as a Regulatory Lead, the responsibilities will include the following in addition (project specific):11. Provide the instruction to team for preparing the submission-required documents12. Cooperate with Clinical Lead and project team to set-up submission timeline and ensure the timeline is achieved as scheduled.13. Highlight common issues and address these with the team as a training need.14. Raise concerns with the Project Manager/Clinical Lead as appropriate*Job Qualifications1. Leadership skills that include the ability to gain trust and confidence with a variety of clients as well as within the company; detail oriented; strong written and oral communications skills, as well as excellent interpersonal skills; motivated to work consistently in a fast-paced and rapidly changing environment.2. Excellent interpersonal, verbal, and written communication skills, (including experience in making presentations at conferences, meetings, training sessions).3. Team player with outstanding interpersonal, negotiation skills and organizational skills.4. Demonstrated ability to manage and motivate direct reports.5. Ability to role model behaviors and ethics in line with PAREXEL APEX Mission, Vision and Values.6. Minimum three years experience in Regulatory Affairs7 A bachelor (or above) degree BS in life sciences or pharmaceutical background or equivalent8 Good communication in Fluent English 职能类别： 药品注册

联系方式

朝外大街乙12 號昆泰國際大廈15樓1505室

公司信息

精鼎医药研究开发(上海)有限公司(PAREXEL International)，成立于1982年，是一家致力于药物临床试验研究的CRO (Contract Research Organization)集团公司。总部位于美国，分支机构遍布欧、美、亚、大洋四大洲，且于亚洲13个国家和地区设立了分支机构，致力深耕于当地。精鼎医药由一群具有丰富跨国性临床试验研发经验及专业知识的精英所组成，服务团队集合各种不同专业领域的人才。我们重视与客户的承诺，更重视人才的培育和养成，我们提供完整的教育训练、职涯规划、优于市场的薪资福利、良好工作环境，期许同仁与公司一同成长，迈向未来。 愿景（Vision）： 创造一个在亚太地区具有国际竞争力的最精良CRO团队。 发展使命（Mission）： 1．争取国际大药厂委托，执行符合国际水准的跨国性临床试验。 2．协助亚太生技及制药产业建立新药开发模式，以提升产品研发能力，幷促使产品国际化。 3．以提升临床试验品质为宗旨，拓展全球市场为目标，整合计算机及通讯科技，在国际上提供客户兼具成本效益及效率的临床试验数据处理中心。 4．建立一个以亚洲人种高发生率疾病的基因数据库，以提供国际性新药研发机构所须之基因信息，协助其缩短药物开发时程，幷提高研发成功率。 公司福利和人才培养计划： 保险类： 1. 社会保险(依照国家规定)及住房公积金； 2. 团体保险（包括寿险、意外暨医疗保险）； 3. 补充医疗保险； 制度类： 1. 学习发展计划 (Learning & Development): 针对个别员工之专业及兴趣，设计符合其个人之生涯规划； 2. 完整的教育训练：每年公司均针对所有员工，提供完整之教育训练； 3. 顺畅的升迁管道及可转调其它部门；如有职缺，亦可申请调至海外各子公司； 请 / 休假制度： 1. 服务第一年即享有14天年假, 后续年休假天数则依据服务年资及公司制度而定； 2. 一年可享12天不扣薪病假； 3. 员工旅游, 年度体检； 精鼎医药将以培养国际性的人才为目标，欢迎具有国际观之人才加入。 应聘方法： 1.    在线投递； 2.    请登录我们的公司网站直接投您的简历（https://jobs.parexel.com/search-jobs） 我们在收到您的简历之后，会尽快与您联系。 谢谢！

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