Objective / Purpose:
Ensure RA operation support for New and Marketed products. Keep close contact with local and global stakeholders and cooperate to RA operation and compliance.
Accountabilities:
Support RA dossier verification check, publishing, submission and archiving. Lead system integration and implementation in China RA, not limited to regulatory information management system (MEDIVA), EDMS. Product artwork system management, including label/PI double confirmation. RA SOP management and SOP training monitoring. Local Regulatory compliance support for RA team, perform gap assessment represent from China RA. Operation support for product IP, timeline update, product registration news, RA access account etc. Other assigned work from line manager
Education & Competencies (Technical and Behavioral):
•Level of Education: Bachelor’s degree or above
•Working Experience in Relevant Field: >=4-year related work experience
•Professional Knowledge and Skills: Excellent communication skills, both verbal and written. Proficiency in English is a must. Skilled in using computer office software
Good skills in English listening, speaking, reading, and writing
Be familiar with the laws and regulations on drug administration and registration management, with stronger communication skills and professional competence.
