天津招聘

Job Responsibilities:

Regulatory (80%)

• Help to deliver and explain China Regulations requirement to HQ.
• Provide preliminary assessment for developing registration strategy.
• Coordinate product preparation for registration lab test; deliver China request to R&D for gap analysis.
• Compile, submit and follow up on product lab test, new registration, variations and manufacturer GMP/QS inspection (if requested by NMPA) to achieve approval.
• Review product labeling and packaging materials in compliance with local regulation and follow up implementation of approval information, i.e. change of China label and package insert.
• Monitor routinely drug regulation and policy changes; inform Guerbet with proactive plan (if could be managed by RA only) or spread out to the responsible department (if cross-function coordination needed).
• Archive submitted dossier and provide a copy to HQ, maintain local registration files and local RA database.
• Good/self-buildup relationship with NMPA, CDE, lab test institute. Efficient communications with China authorities with well tracking record.
• Handle Import Drug License if require to help for customs clearance or declaration

Others (20%)

• Support in providing documents on drugs as required by cross functions, i.e. QA, AE, complaints, etc. upon approval of China RA manager or GM.
• Support other tasks with RA expertise to external partner or Guerbet internal, i.e. product profile summary; commercial lab test; communication bridge between local team and HQ RA.
• Help in reviewing commercial tools from RA point of view to have them aligned with local regulation, PI and SMPC.
• Support PV when assessing, renewing CCSI.
• Other tasks as required by the company.

Job Requirements:

• Above 2-3 years' RA experience in drug, esp. on import drug registration. Nice to have sense on medical device registration;
• Professional level in written and spoken English
• Bachelor or higher degree. Pharmaceutical or biochemistry related academic background preferred;
• Good communications and interpersonal skills;
• Good writing and oral English skill;
• Multitasking management, Sharing, Passion, Cooperative;
• Detail-oriented and work according to procedures, rules and regulations.

All information submitted to us will be kept strictly confidential and will be used for recruitment purpose only.

自1926年起，加柏集团，这一医疗成像对比剂产品的研究开发领域的先驱者已经建立起了其悠久的传统。加柏公司总部位于法国巴黎，是一家上市公司，其在欧洲对比剂市场的市场份额为25%在全世界的市场份额为7%。

加柏充分利用其专业知识及创新能力，迎接21世纪公共卫生领域的重大挑战。

我们的团队为重大疾病（癌症，心血管、感染，神经变性疾病）的诊断技术进步做出了卓越的贡献。我们新型高效的成像解决方案为全世界的患者保证了更好的治疗方案。