职位详情

RA技术顾问(外派)

30,000-49,999

上海 5-10年 本科
方恩(北京)医药科技发展有限公司

医药企业 其他 500~999人

职位描述
·Serves as the onsite support to manage & execute local SMPprojects & regulatory maintenance of local markete********;coordinate with region SMP & other functions as necessary
·Manage & making sure local regulatory SMP tasks& regulatorymaintenance are delivere******** time with appropriate quality&compliance according to external an******** standards an********
§ Atten******** meetings for assigne******** projects & RegulatoryMaintenance of markete******** (JNJ AP product portfolio: sk******** OTCetc.)
§ Develop Project Implementation plans an******** regulatory actionitems; e.g.
o mapp******** coordination with LRA for regulatory inputsresultingfrom changes in pro******** documentation re******** timelines forregistration******** an********-in of changes (e.g., ingredients &formulation rev******** AW / labelling changes an******** /International documentation)
o Coordinate preparation of quality & compliant country submissiondocuments to health authorities
o Regulatory processes & systems support e.g. GCC, Opt********regulatory database
§ Provide weekly update (at a minimum) to reg******** J&J MRS SMPliaisonagainst KPIs
§ Prepare management reports slide presentations for managementbriefings
§ Immediately raise issues for concern or potential business risks&disruption
§ Be the local lea******** SMP / markete******** regulatory maintenance
§ Review Regulatory operations work to assure ******** compliancean******** of output
§ Proactively addre******** resolve any performance issues
§ Propose working process an******** improvements
Educational & Language Requiremen********
Life Science Degree or equivalentrelevant qualificationMust beproficient in oral & written of the local language at theonsite location; an******** level of English language for businesscommunication

Experience Required:
Minimum of 5 years relevant work experienceExperience in ProjectManagementExperience of working within a regulate******** (e.g.,pharmaceut******** cosmet******** foo********, etc.) an********awareness of regulatory affairs.
Skill********
Demonstrate excellent communication skillsStrong interpersonal skillsan******** to deal effectively with a variety of personnel includingme******** scientific & manufacturing Well organ********detail-oriented–excellent attention to details
职位要求
  • 专业要求: 临床医学,药学
  • 最低学历: 本科
  • 工作年限: 5-10年
工作地点
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