Assistant Manager of RA 北京

月薪： 20-30万/年

该公司所有职位
  • 3-4年经验
  • 本科
  • 招若干人
  • 02-01 发布
  • 五险一金
  • 补充医疗保险
  • 员工旅游
  • 交通补贴
  • 餐饮补贴
  • 通讯补贴
  • 定期体检
  • 年终奖金

职位描述

Job Description:New dossier preparing and filing, mainly on reviewing new dossier as per CFDA requirements, ensure timelines are being followed; consolidation of final dossier and filing to CFDA.Finished BE notifications for BE tests, mainly reviewing notification dossier as per CFDA requirements, ensure timelines being followed.Samples supplying /Dealing with Regulatory Authorities, including assisting to Buy the required equipment, reagents and reference standards, preparing documents for submitting to NIFDC and PQC, arranging import permission letters, dealing with custom clearance of consignments, interaction with the Head office to ensurecorrectness of documents to avoid the problems at China Customs of sample import.Filing products regulatory following up, and Making representations to CFDA from time to time in clarifying and seeking clarity on product registration process, queries from CDE or PQC etc.Partly dossier translation from English into Chinese or vice versa.Requirements:1 Bachelor or Master degree in pharmacy or related discipline.2 Good communication, learning and computer operation skill.3 Good at English writing, reading and speaking.4 At least 5-6 years of experience in regulatory affairs or R&D area. 职能类别： 药品注册 医药技术研发人员

联系方式

光华路东方梅地亚中心

公司信息

Dr. Reddy’s Laboratories Ltd. (NYSE: RDY), herein referred to as Dr. Reddy’s, is an integrated global pharmaceutical company established in 1984, which is committed to providing affordable and innovative medicines for healthier lives. Through its three business-Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products, Dr. Reddy’s offers a portfolio of products and services including Active Pharmaceutical Ingredients (APIs), Custom Pharmaceutical Services (CPS), generics, bio-similars, differentiated formulations and News Chemical Entities (NCEs). The company enjoys a strong presence in the U.S., U.K., Germany, Russia and CIS, Romania, Venezuela, China, South Africa and New Zealand. Dr. Reddy’s corporate offices are located in Hyderabad, India. The total revenue of Dr. Reddy’s was USD $2.20 Billion as on 31st March, 2014. For more information, pls visit www.drreddys.comIn China, Dr. Reddy’s Laboratories Ltd. operates through its joint venture with Rotam Group of Canada. The joint venture is widely known as Kunshan Rotam Reddy Pharmaceutical Company Ltd. (KRRP) with a local manufacturing facility located in Kunshan, Jiangsu Province. KRRP was established in year 2000 complying with China laws with a total investment of USD29.99 million.

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