更新于 11月17日
职位描述
新药注册进口药品注册生物制品化学原料药
Company Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
Job Description
Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.
Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.
Office-based in Shanghai/Beijing
Your role:
- Liaises with project teams to procure documents necessary for regulatory and ethics committee submissions.
- Prepares regulatory and ethics committee submission dossiers, including applications for import and export licenses.
- Reviews translations of essential documents subject to regulatory or ethics committee submissions, if regionally applicable (shared with project teams).
- Tracks regulatory project documentation flow and progress reporting.
- Tracks changes/amendments to legislative acts pertaining to clinical trials in PSI countries and timely notifies all parties involved.
- Under supervision maintains a database of regulatory requirements
- Liaises with project teams to procure documents necessary for regulatory and ethics committee submissions.
- Prepares regulatory and ethics committee submission dossiers, including applications for import and export licenses.
- Reviews translations of essential documents subject to regulatory or ethics committee submissions, if regionally applicable (shared with project teams).
- Tracks regulatory project documentation flow and progress reporting.
- Tracks changes/amendments to legislative acts pertaining to clinical trials in PSI countries and timely notifies all parties involved.
- Under supervision maintains a database of regulatory requirements
Qualifications
- Bachelor's or above Degree in Medicine, Pharmacy and relevant Life Sciences major
- At least 5 years experience with clinical trial submissions in China
- Full working proficiency in English and Mandarin
- Proficiency in MS Office applications
- Detail-oriented
- Ability to learn, plan and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
- Bachelor's or above Degree in Medicine, Pharmacy and relevant Life Sciences major
- At least 5 years experience with clinical trial submissions in China
- Full working proficiency in English and Mandarin
- Proficiency in MS Office applications
- Detail-oriented
- Ability to learn, plan and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
工作地点
朝阳区北京国贸大厦16号楼23层2357室
公司信息
辟埃赛医药科技(上海)有限公司
不需要融资 · 20-99人 · 医药研发/生产外包（CXO）
已审核
公司介绍
PSI is a leading full-service global Contract Research Organization providing a wide range of clinical trial services to the pharmaceutical and biotechnology industry, mainly for the development of clinical drugs. PSI has 2,200+ employees and 40+ affiliates in Europe, North and South America, Asia Pacific and South Africa. PSI是一家提供全方位服务的全球临床试验项目承包商，为制药和生物技术行业提供广泛的临床试验服务，以帮助临床药物的开发。PSI在欧洲、北美和南美、亚太和南非拥有2200多名员工和40多家分支机构。
工商信息
企业名称 辟埃赛医药科技（上海）有限公司
企业类型 有限责任公司（外国法人独资）
法人代表 Angelika Ruf
经营状态 存续
成立时间 2019-02-28
注册资本 20万瑞士法郎
认证资质
营业执照信息
