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无工作经验 -
本科 -
招1人 -
11-09 发布
- 五险一金
- 补充医疗保险
职位描述
职位描述： Job Responsibilities: This job will be based in Shanghai currently and will be based in Nantong after the site operation.l As regulatory SME (subject matter expert) of Active Pharmaceutical Ingredient (API), Excipients, food additive and site regulatory responsible person to provide regulatory support to Merck Life Science NMCC project and Merck Life Science Nantong site in the future. Job include but not limited─ Evaluate the requirements of drug manufacturing license, manage the application of drug manufacturing license and maintain the license.─ Evaluate the requirements of food additive manufacturing license, manage the application of food additive manufacturing license and maintain the license.─ Prepare and submit the excipient bundling review dossier for the excipients made in Nantong site.─ Monitor the regulation and national standards updates related with products made by Nantong site and ensure the timely internal communication.─ Prepare the registration dossier for APIs made in Nantong site, apply and maintain the API license if need.─ Collaborate with site quality to support GMP certification if need.─ Liaison with local FDA to facilitate the communication between the site and authority.─ Daily site regulatory affairs worksl Provide regulatory support to biological material’s importation for Nantong site and ensure the regulatory compliance.─ Coordinate related function departments to drive, manage biologics material’s compliance importation.─ Prepare documents for import permit application, submit and follow up application process with local authority, make sure get import permit approval per plan.─ Keep good connection with local authorities (AQSIQ, local CIQ), monitor relevant regulation changes and ensure the timely internal communication.─ Coordinate to provide regulatory consultancy and strategy for new biological material’s importation. Qualifications:Education and Languages:² Technical degree required, biopharmaceutical, bioscience related science² Fluent in Chinese native & English (verbal and written) is required. Professional Skills and Experience:² Experience of minimum 6 years in pharmaceutical/API/excipient regulatory affairs, extensive knowledge about China regulations of biological material’s importation is a plus.² Fluent to use Microsoft office software.² Experience working in a global, matrix environment.² Excellent interpersonal, presentation, listening and communication skills.² Strong organizational and time management skills.² Ability to indirectly influence other organizations and cultures. 职能类别： 生物工程/生物制药
联系方式
江苏南通经济技术开发区
公司信息
北京外企德科人力资源服务上海有限公司（简称 FESCO Adecco 外企德科）是中国人力资源服务行业最具竞争力和品牌价值的FESCO与全球人力资源服务行业领航者Adecco成立的一家中外合资人力资源服务企业，为企业及个人提供业务外包、人事服务、招聘猎头和员工福利等相关人力资源解决方案。 成立于1979年，FESCO拥有悠久的人力资源专业化服务历史、丰富的市场经验以及完备的服务资质，是中国人力资源服务行业的领跑者，Adecco则是全球人力资源行业的巨头，服务网络遍布全球60多个国家和地区。FESCO Adecco成立后，双方通过优势互补，整合了客户资源，依托全球化的资源和服务平台，融合本土网络优势，扩大了业务范围，为客户提供全方位的业务流程外包（BPO）、财务外包与薪酬管理、人事委托/人事派遣、全球化派遣、人才招聘/RPO相关服务、健康福利与弹性福利等人力资源解决方案。合资后的FESCO Adecco飞速发展，并且在浙江、重庆、深圳、苏州设立了分支机构。目前，FESCO Adecco在中国每天服务达100万名员工，服务客户近12,000家。 FESCO Adecco致力于成为最专业的人力资源全面解决方案提供商，成为客户最值得信赖的人力资源合作伙伴。为客户打开通向国际市场及创新型人力资源服务模式的大门，推动中国乃至全球的人力资源外包产业的健康发展。
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