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无工作经验 -
招1人 -
11-09 发布
- 五险一金
- 补充医疗保险
- 餐饮补贴
- 弹性工作
职位描述
职位描述： Primary purpose and function of this position:To lead and proactively manage all regulatory activities associated with development, registration and maintenance of Drug Master Files according to current international regulatory requirements.Duties and Responsibilities:oSupport the life cycle management of APIs from RA perspective and resolve difficulties rose during development, review and commercialization periodsoReview and approve ROS, specification and analytical control when requiredoCoordinate DMF preparation and related activities for On Time Submissions for all relevant marketsoProactively collaborates with the Regulatory Specialist team members, which support the submission or answer service requestsoPrepare a DMF specific high level gap analysis report and proactively communicate any risk to the relevant departments. Follow up on the gaps' solving during the review periodoRespond to deficiency letters and coordinate related activitiesoIdentify new trends in deficiency letters received and work to prevent them in future submissions.oCoordinating pre-launch activities from RA perspectiveoManages the regulatory aspects and related tasks of the assigned commercial APIsoEvaluate change requests and address the required submission per market to support the requested change. Follow through the submissionoMaintain up to date the DMFs according to the required regulation of updating per market.oSupport customers regarding Service Requests, giving relevant professional information in the shortest of timeoContinue learning of regulatory guidance, SOPs and work processesoProactively suggest and support development/improvement of RA work processes in order to achieve constant improvement of our departmentoTrain new RA associate on specific subjects when asked tooGuide RA department on relevant subjects?Job Requirements:CapabilitiesoGood human communicationsoHigh service approach to internal & external customersoGood Leadership and communication skillsoOrganizedoWide and open viewoSelf- learning capabilitiesoIndividual work abilityoComprehensive workoHigh writing skillsoMeeting work target time linesoAccuracyoReadiness to work when requiredoInitiativeoSelf-motivatedoTime managementoEnglish good professional level, both in writing and speakingEducationHigh degree in relevant field, e.g. chemistry/biochemistry/biology or biotechnology 职能类别： 药品注册
联系方式
北京市西城区裕民路18号北环中心1209室，
公司信息
万宝盛华成立于1948年，公司年度总收益超过220亿美元，为雇主提供涵盖整个雇佣生命周期和商业周期的一系列服务，包括人才推荐服务、临时和合同派遣服务、员工测评和筛选、培训服务、转职推荐服务、外包和咨询服务等。万宝盛华集团——全球开创性的人力资源解决方案的领导者——于1994年首次将业务拓展至中国大陆，提供全方位的人力资源服务。
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