Senior RA Operations Officer

中国, 北京, Beijing

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Job Summary岗位简介

  • 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

Education/Qualifications

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                                      

                                   

Travel Frequency

<25%