- 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.
- 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。