Principal Duties and Responsibilities (General Summary, essential functions
and authorities, etc.)
主要工作职责（基本概况，主要功能，权限等）
法规事务专员由其直线经理监督管理。法规事务专员负责多个法规事务项目的计划、执行和交付，以实现公司重大目标。法规事务专员负责在直线经理的监督管理下计划并执行所分配项目的注册工作；负责协调不同跨职能部门之间的工作，包括研发、生产、质量、医学事务、临床、法务以及其他职能部门，以满足项目注册之需要。本职位要求具备相应的法规和产品知识、一定的协调能力、沟通能力与执行能力，这些都会直接影响业务部门的运营结果。
RA Specialist is under the supervision from their line manager. They will be
responsible for planning, execution, and delivery of multiple RA projects to
achieve significant company goals. RA Specialist plan and execute the
registration activities for assigned projects under their line manager’s
supervision. They coordinate activities of various cross-functional departments
including research & development, manufacturing, quality, medical, clinical,
legal, and other functions to meet the needs of project registration. This role
requires regulation and product knowledge, coordination, communication skills
and execution which directly impact the operational results of the business
unit.
主要职责/任务（以时间的百分比表示）：
Key responsibilities/tasks （indicate estimated % of time spent where
possible）：
70% 产品注册准备和执行。
70% Product registration preparation & execution.
10% 制定注册项目计划。
10% Develop registration project plan.
10% 为法规合规工作提供支持。
10% Support regulatory compliance activities.
10% 法规信息收集、解读和政策制定。
10% Regulatory intelligence collection, interpretation and policy shaping.
职责/主要衡量指标：
Accountabilities/Key measures：
根据注册（以及延续注册）策略和注册项目计划，计划并执行项目注册工作。
Plan and execute project registration activities according to the registration
(and renewal) strategy, registration project plan.
准备注册资料和产品技术要求。
Prepare the registration dossier and product technical requirement.
与项目团队密切合作，以确保注册工作按照项目时间表进行。
Work closely with project team to ensure registration activities meeting
project timeline.
与直线经理共同为法规事务部和跨职能项目团队成员确定项目或项目的优先级。
Define priorities together with line manager on assigned projects or across
multiple projects, for RA and cross functional project team members.
支持其他部门的工作，及时审阅相关变更，提供法规支持。
Support other function activities and review related changes on time with RA
support.
支持内部/外部审计。为团队提供法规指导。
Support the internal/external audit. Provide regulatory guidance to team.
维护与内部合作伙伴，包括全球法规事务部，本地质量、研发和生产部门的合作关系。与这些职能部门的合作伙伴有效地沟通。
Maintain the relationships with internal partners, including global RA, local
quality, R&D and Manufacture. Effectively communicate with these functional
partners.
鉴别、评估并解读新政策与法规，以支持产品开发和注册。
Identify, evaluate and interpret new policies and regulations for product
development and registration.
积极参与到国行标制修订的相关活动中，支持强生项目和业务。
Actively participant in the creation and revision of GB/YY standard, to
support J&J projects and business.
了解并遵守强生的信条和基于信条价值观的决策。执行部门战略。
Understand and adherence to J&J Credo and value of Credo based decision.
Execute departmental strategy.
不断学习公司相关技术、政策和产品知识以及业务流程，以提高职业技能和工作效率。
Keep learning company related technical, policy, product knowledge, business
process to develop professional skill and work efficiency.
严格保守公司机密信息并维护公司知识产权，包括产品研发信息、设计、生产流程、商业机密、政府汇报和法律事宜、销售额和市场策略。
Strictly maintain confidential information and intellectual property (IP)
includes product development information, designs, manufacture process, trade
secrets, government reporting and legal matters, sales volumes and marketing
strategies.
负责将业务相关问题或机会沟通到上一级管理层。
Responsible for communicating business related issues or opportunities to next
management level
确保个人、并驱动公司对药监和公司相关法规、政策和程序的遵守。
Ensure personal compliance, and drive for company compliance with Healthcare
Authority and Company related regulations, policies, and procedures.
与医疗器械监管部门的联络和沟通，如NMPA、CMDE、JSMPA 等.。
Connection and communication with medical device healthcare authority, such as
NMPA,CMDE, JSMPA etc.
执行其他必要的职责。
Performs other duties assigned as needed
Basic Requirement, including Education and/or Knowledge and/or Training and/or
key Relevant Experience required.
基本任职资格（包括教育背景和/或知识和/或培训和/或相关工作经验）
大学学位或研究生技术学位。
University Degree or Post Graduate Technical Degree.