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崗位：注冊專員
Department: Regulatory Affairs -
Imported
所屬部門 法規(guī)事務(wù)部 - 進口
Job Title of Direct Supervisor
Regulatory Affairs Manager
直接主管（崗位名稱） 注冊經(jīng)理
1. Principal Duties and Responsibilities
(General Summary, essential functions and authorities, etc.)
主要工作職責(zé)（基本概況，主要功能，權(quán)限等）
I. Registration 注冊：
a) Plan: Well know assigned
products' registration plan (renewal/change/Filling) and prioritization defined
by supervisor; know how to execute the plan by quarter/month/week/day;
frequently track the implementation status 計劃：充分了解指定產(chǎn)品的注冊計劃（延續(xù)注冊/變更注冊/備案注冊事項）和主管確定的注冊工作優(yōu)先次序；知道如何按季度/月/周/天執(zhí)行計劃；經(jīng)常跟蹤計劃實施狀態(tài)
b) Strategy: have basic sense on
registration pathway, classification, timeline, review preference… 策略：對注冊路徑、分類、時間表、審查偏好有基本了解
c) Execute: compile the registration
dossier per most updated NMPA requirements; order sample and follow type
testing, to meet registration timeline; prepare eRPS submission and complete
payment by due; closely track status in CMDE; handle reviewers questions and
provide supporting documents per request; complete filling & database
accurately input after approval 執(zhí)行：根據(jù)中國國家藥品監(jiān)督管理局（“NMPA”）的最新要求編制注冊申報資料；訂購樣品并進行型式測試，以滿足注冊時間表的要求；編寫eRPS注冊申報文件并按時完成付款；密切跟蹤中國國家藥品監(jiān)督管理局醫(yī)療器械技術(shù)審評中心（“CMDE”）顯示的注冊狀態(tài)；處理審評員提出的問題并根據(jù)要求提供支持文件；獲批準之后填寫相關(guān)表格并準確錄入數(shù)據(jù)庫
II. Communication & escalation: clearly describe the questions/needs, timely ask WWBU RA for
documents & support; communicate with China cross function members on
registration status; clearly communicate with reviewers on dossier contents;
frequently communicate with supervisor to report progress and escalate
risks/issues. 溝通與上報：清晰描述問題/需求，及時向全球業(yè)務(wù)部門法規(guī)事務(wù)部（WWBU RA）索取文件和支持；與中國跨職能團隊成員就注冊狀態(tài)進行溝通；與審評員就注冊申報資料的內(nèi)容進行清晰溝通；經(jīng)常與主管溝通，以報告工作進度并上報風(fēng)險/問題。
III. Post Market Compliance: maintain related database accurately; execute routine after-approval
processes e.g. Chinese labeling, copy review etc ; timely assess change
notification of LCM products, trigger necessary registration activities
immediately; support post market actions e.g. audit, inspection, recall… 上市后合規(guī)性：準確維護相關(guān)數(shù)據(jù)庫；執(zhí)行例行的批準后流程，例如貼中文標簽、文案審查等；及時評估LCM產(chǎn)品的變更通知，立即觸發(fā)必要的注冊活動；支持上市后舉措，例如審核、檢驗、召回
IV. Process Excellence: follow company SOP/WI/guidance on routine processes; think about
improvement & speak out ideas 流程優(yōu)化：遵循公司標準操作程序（SOP）/作業(yè)指導(dǎo)書（WI）/常規(guī)流程指南；思考改進并提供思路
V. Policy shaping: Curiosity and passion for new regulation, policy, standards and
technologies; be aware of NMPA/CMDE/Lab common working processes; correctly
interpret key regulatory requirements by self-learning or participating training
and deliver to WWBU RA & other function members. 政策思維塑造：對新法規(guī)、政策、標準和技術(shù)懷有好奇心和熱情；了解NMPA/CMDE/實驗室常見工作流程；通過自學(xué)或參與培訓(xùn)正確解讀關(guān)鍵法規(guī)要求，并傳授給全球業(yè)務(wù)部門法規(guī)事務(wù)部和其他職能部門的成員。
VI. know JNJ
& BU routine operation 了解強生與業(yè)務(wù)部門（“BU”）的常規(guī)業(yè)務(wù)操作

build up basic self management skills,
project management, time management, presentation, etc; good
Document # 文件號: GOP-03-002 Version # 版本號: F Page 頁碼: 8 / 9
sharing & teaming spirit; actively
absorb knowledge from others & trainings 塑造基本的自我管理技能、項目管理、時間管理、演示宣講等技能；具有良好的分享和團隊精神；積極吸收來自他人傳授和從培訓(xùn)中獲得的知識
Other responsibilities defined in written procedures.
流程中規(guī)定的其它職責(zé)。
2. Basic Requirement, including
Education and/or Knowledge and/or Training and/or key Relevant Experience
required.
基本任職資格（包括教育背景和/或知識和/或培訓(xùn)和/或相關(guān)工作經(jīng)驗）
I. Education Background: B.S. or above; Prefer in medical, material, mechanical/biomechanical
engineering or pharma 教育背景：理學(xué)學(xué)士或以上學(xué)歷水平；首選醫(yī)學(xué)、材料學(xué)、機械學(xué)/生物力學(xué)工程或制藥學(xué)專業(yè)
II. Work experiences: Prefer 1~3 years experiences before joining JNJ 工作經(jīng)驗：加入強生前有1~3 年相關(guān)工作經(jīng)驗者優(yōu)先