Beijing, CHN
21 hours ago
RA Operations Associate Manager
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice (https://jobs.takeda.com/privacynotice) and Terms of Use (https://www.takeda.com/terms-and-conditions/) . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** **_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. **Locations** Beijing, China **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time
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