RA Manager/注册经理 (1年期合同)

该职位来源于猎聘 FSP Top Global Pharma RESPONSIBILITIES: -Contribute to regulatory strategies development and registration timeline acceleration. Provide regulatory risk assessment and mitigation plan for relevant projects and ensure timely completion of the registration tasks assigned, in compliance with regulations, guidelines and internal processes.

• Work with area and global team to prepare and review registration dossier to ensure scientific rigor, accuracy, and clarity
• Compile submission packages and ensure timely submission upon internal review and approval
• Prepare response docuemnts as requested by regulatory authorities
• Monitor regualatory authorities’ review and approval processes, keep local project team advised of the progress, and discuss critical issues and potential solutions before implementation
• Handle QC validation testing, resolve technical issues to ensure timely completion
• Design and modify Chinese artworks for package insert, pack and label, in line with relevant regulatory requirements
• Review promotional and educational materials to ensure compliance
• Collect information on competitive products, provide regulatory supports and advices to other personnel in China affiliate
• Maintain all regulatory documentation
• Assist line manager to complete urgent assignment as requested in a time manner Requirements:
• Over 7 years regulatory affairs experiences in pharmaceutical or biotech industry
• Working experience with multinational company
• Experience with clinical trial application and/or new drug applications
• Familiar with regulatory guidelines and requirements
• Good written and oral communication skills in both English and Chinese
• High scenes of work quality, looking into details
• Good communication skill, team work
• Fast learning capability