Senior Specialist, Regulatory Affairs
Principal Duties and Responsibilities (General Summary , essential functions and authorities, etc.)
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I. Registration
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a) Plan: Well know assigned products' registration plan (new/renewal/change/others) and prioritization defined by supervisor; know how to execute the plan by quarter/month/week/day; frequently track the implementation status
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b) Strategy: have basic sense on registration pathway, classification, timeline, review preference…
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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
??: ?????????????(“ NMPA”)?????????????;???????????,???????????;?? eRPS ?????????????;?????????????????????????(“ CMDE”)???????;?????????????????????;???????????????????
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.
?????: ??????/ ??,??????????????( WWBU RA)???????;???????????????????;????????????????????;???????,????????????/ ???
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 immedicately; support post market actions e.g. audit, inspection, recall…
??????: ?????????;??????????,?????????????;???? LCM ???????,???????????;???????,??????????……
IV. Process Excellence: follow company SOP/WI/guidance on routine processes; think about improvement & speak out ideas
????: ??????????( SOP)/ ?????( WI)/ ??????;?????????
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.
??????: ?????????????????????;?? NMPA/CMDE/ ?????????;???????????????????,??????????????????????????
VI. know JNJ & BU routine operation
?????????(“ BU”)???????
VII. build up basic self management skills, project management, time management, presentation, etc; good sharing & teaming spirit; actively absorb knowledge from others & trainings
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Other responsibilities defined in written procedures.
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