【上海【大外资RA岗位】药品注册专员/高级专员招聘】-猎头顾问上海招聘信息-猎聘

王先生 2天前在线已认证

猎头 · 上海御净企业管理咨询有限公司

聊一聊

职位介绍: MNC药企正式合同，base 北京上海都可 1.Work with a cross functional team on the registration dossiers preparation and submission based on registration plan and the HA requirement for both new products and marketed products. -Participate in the development of RA strategy and action plan. -Compile registration dossiers and ensure timely regulatory submission and approval. -Communicate with the HA on product registration, including pre-application meetings, sample testing, and so on. 2.Monitor the overall review process and respond to additional data requests, technical queries, and deficiency letter from the HA, and ensure the set registration strategy and timeline being implemented on time. -Closely follow up on the HA review process. -Maintain adequate product knowledge to ensure prompt and professional responses to queries. -Submit responses to deficiency letters within the stipulated or agreed timeframes. 3.Maintain an up to date knowledge of the relevant laws, guidelines, and other regulatory information for appropriate registration planning and implementation. 4.Ensure regulatory compliance. -Maintain and update product inserts and labels in accordance with relevant regulations. -Ensure the timely submission of all quality and safety relevant variations including labelling safety update and specification/manufacturing process change in accordance with relevant regulations and company’s SOP. 5.Support for business and commercial. -Routine review & approval of promotion materials. -Support commercial and logistics team from a regulatory perspective, help to keep stock balance, ensure technical problems be solved in time. -Provide product relative registration documents and/or explanations as per commercial needs. 任职要求： Bachelor degree in pharmacy, medical or related background CET-6 or above 2~3 years’ regulatory affairs working experience in pharma industry Fluency in communicating (written/oral) in English Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance

其他信息: 语言要求：普通话 + 英语; 行业要求：制药

猎聘温馨提示：

1. 如您发现平台内招聘方存在以下违规行为的，请立即举报

· 扣押您的身份证件或者其他证件；
· 要求您提供担保人、担保金或者以其他名义向您收取财物（如培训费、体检费、资料费、置装费、押金等）；
· 强迫您入股或者向您集资；
· 以招聘名义牟取不正当利益；
· 发布虚假招聘广告信息；
· 工作时长违反劳动法规定；
· 存在其他损害您的合法权益的行为。

2. 如您应聘的岗位属于涉外劳务合作/海外岗位的，请务必核实招聘方对外劳务合作资质取得情况，同时注意自身资金安全，防范招聘欺诈。

猎聘温馨提示：

猜你喜欢