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12-01 发布
- 五险一金
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职位描述
职位描述： Job ProfilePosition: Executive/Senior Executive of RA Location: Beijing Reporting to: Manager/Head of China RAResponsibilities:1.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.2.Finished BE notifications for BE tests, mainly reviewing notification dossier as per CFDA requirements, ensure timelines being followed.3.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 ensure correctness of documents to avoid the problems at China Customs of sample import.4.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.5.Partly dossier translation from English into Chinese or vice versa.Requirements:1. Bachelor or Master Degree in pharmacy, biological sciences or related discipline.2. At least 3-7 years working experience in R&D or Regulatory Affairs, preferable to experience in generic products regulatory affairs at least 2-4 years.3. Good communication skill, creative thinking, with teamwork spirit,4. Good at English writing, speaking, and listening. 职能类别： 药品注册
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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