- Preparing regulatory compliance dossier for various applications which submit to China Health Authority.
- Provide timely and compliant business support per request from internal and external stakeholders.
- Support China eCTD implementation in Roche stick to HA’s requirements.
- Be responsible for other regulatory operations related activities.
- Observe and optimize internal working process.
- Support line-manager on relevant initiative activities.
Job required competency 岗位所需胜任力
- Support regulatory submission dossier publishing, archiving, tracking and all the related activities in compliance with internal and external requirements
- Responsible for coordinating with venders and fulfill budget control requirements.
- Responsible for timely response and satisfy business requirements (sample import/CPP Coordination/PoA Coordination...) from internal (RA/Clinical/Marketing...) or external (HA/RDPAC...) stakeholders.
- Perform relevant activities in compliance with COMRMAP (Corporate Records Management Programme) within PDR China
- Facilitate implementation of China eCTD in Roche via closely cooperate with global operations team and industry.
- Responsible for other daily operation work. Support line-manager on China eCTD project and following up all the subsequent activities.
- Makes valuable contributions to the development of regulatory Operations practices, procedures and standards.
- Develops internal and external network to obtain information and intelligence
- Leadership competency
-Addresses and resolves conflict by creating an atmosphere of openness and trust
-Works effectively with other people over whom he or she has no direct authority
-Be good at promoting an idea or vision
Basic Qualification and Experience 基本能力与经验
B.S. or above
Relevant working experience:
* ≥4 years’ working experiences, Pharmaceutical regulatory operations is preferred
* independent working
* experience in drug/biologic is a plus
Language and PC Skills:
Chinese (mother-tone level) and English (proficiency level)
Computer skill: word, excel, power-point