欧美在线视频,乱熟女高潮一区二区在线 ,女厕精品toilet,免费看成人啪啪

崗位：注冊專員
Department: Regulatory Affairs -
Imported
所屬部門 法規事務部 - 進口
Job Title of Direct Supervisor
Regulatory Affairs Manager
直接主管（崗位名稱） 注冊經理
1. Principal Duties and Responsibilities
(General Summary, essential functions and authorities, etc.)
主要工作職責（基本概況，主要功能，權限等）
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：充分了解指定產品的注冊計劃（延續注冊/變更注冊/備案注冊事項）和主管確定的注冊工作優先次序；知道如何按季度/月/周/天執行計劃；經常跟蹤計劃實施狀態
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 執行：根據中國國家藥品監督管理局（“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督管理局醫療器械技術審評中心（“CMDE”）顯示的注冊狀態；處理審評員提出的問題并根據要求提供支持文件；獲批準之后填寫相關表格并準確錄入數據庫
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，及時向全球業務部門法規事務部（WWBU RA）索取文件和支持；與中國跨職能團隊成員就注冊狀態進行溝通；與審評員就注冊申報資料的內容進行清晰溝通；經常與主管溝通，以報告工作進度并上報風險/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… 上市后合規性：準確維護相關數據庫；執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產品的變更通知，立即觸發必要的注冊活動；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 流程優化：遵循公司標準操作程序（SOP）/作業指導書（WI）/常規流程指南；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、政策、標準和技術懷有好奇心和熱情；了解NMPA/CMDE/實驗室常見工作流程；通過自學或參與培訓正確解讀關鍵法規要求，并傳授給全球業務部門法規事務部和其他職能部門的成員。
VI. know JNJ
& BU routine operation 了解強生與業務部門（“BU”）的常規業務操作

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中獲得的知識
Other responsibilities defined in written procedures.
流程中規定的其它職責。
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/或培訓和/或相關工作經驗）
I. Education Background: B.S. or above; Prefer in medical, material, mechanical/biomechanical
engineering or pharma 教育背景：理學學士或以上學歷水平；首選醫學、材料學、機械學/生物力學工程或制藥學專業
II. Work experiences: Prefer 1~3 years experiences before joining JNJ 工作經驗：加入強生前有1~3 年相關工作經驗者優先