RA Head（注册负责人)

该职位来源于猎聘 工作职责

Main responsibilities： 1.负责国内外注册事务，为注册SOP提供意见和建议，确保注册政策推进和实施 As a backbone function for RA at home and abroad, provide comments and suggestions to RA SOP and ensure its implementation worldwide.

• 提供注册支持和培训，以提高注册团队的能力和水平 Provide regulatory knowledge management and training to enhance RA's competency and capability. 3.制定产品注册策略和计划，组织编写TPP、IB、CDS、药品说明书、RMP，跟踪产品注册进度; Formulated product registration strategies and plans, organized the writing of TPP, IB, CDS, drug instructions and RMP, and tracked the progress of product registration; 4.负责与药品监督检验相关部门及其他政府部门沟通; Responsible for communication with related drug administration and inspection departments; 5.及时关注注册规例、指引原则及政策的变化 Keep abreast of changes in registration regulations, guiding principles and policies. 任职要求

Qualifications： 1.药学、药理学、化学或生物科学专业本科以上学历 Bachelor or above in pharmacy, pharmacology, chemistry or the biological sciences. 2.10年以上注册经验，至少8年与当地药监部门沟通经验。 Over 10 years’ experience in Regulator Affairs. At least 8 years of experience in contacting with the local Regulatory Agency. 3.书面及口语英语流利 Fluency in oral and written English. 4.良好的表达能力 Convincing presentation skills are required.