Publishing&Submission Specialist

该职位来源于猎聘 Accountabilities

• E-Submission Dossier QC according to CDE guidance and related SOP.
• Dossier e-chop for submission packaged according to related regulation and SOP within the time limit. And trace/evaluate potential technical issue impact.
• Submission related software trace and maintain. Include e-signature Ukey, e-signature related software, BJCA certificate assistant, application form technical support, submission validator, CDE publishing tool etc. Also, necessary system training provide and maintains.
• Purchase order initiated for RA team via internal procurement system.
• Registration dossier and registration sample archiving management.
• Ensure regulatory activity to meet with related SOP and working procedure
• Other assigned work from line manager QUALIFICATIONS:
• Bachelor’s degree or above majored in medicine, pharmacy, chemical ,biological,etc.
• Working Experience in Relevant Field: ＞1-year related work experience
• Excellent communication skills.
• Skilled in using computer office software.
• Basic skills in English listening, speaking, reading, and writing;