Regulatory Affairs Director 苏州

月薪： 20-30万/年

该公司所有职位
  • 10年以上经验
  • 本科
  • 招1人
  • 01-05 发布

职位描述

The Position is responsible for the supervision and coordination of regulatory efforts in China relating to the submission of new products, post approval submissions and amendments to support the company’s marketed products.任职要求：1. Bachelor degree or above;2. above 10 years of experience in Regulatory Affairs in pharmaceutical industry with minimum of 5 years regulatory affairs management experience;3. Fluent English;4. Knowledge of China regulatory policies and requirements, and Judgment and Strategic think in getting product registered;5. Ability to influence at all levels of the company; work independently as required using sound judgment ability to form, lead and manage cross-functional, cross-business teams;6. demonstrated project management skills and the ability to prioritize, plan & evaluate deliverables to established strategic goals.7. Ability to focus on details. 职能类别： 药品注册

联系方式

苏州工业园区群星一路58号

公司信息

Amerigen Pharmaceuticals is a multinational company with established development and manufacturing platforms aimed at providing high-quality generic pharmaceutical products. Its headquarter is based at New Jersey, US. 爱美津制药是一家集研发和制造于一体的跨国公司，旨在向美国提供高质量的仿制药品。总部位于美国新泽西州。 With pharmaceutical assets and science-based expertise in the United States and abroad, Amerigen is able to provide quality products at competitive prices along with unmatched customer service. 凭借在美国和海外的制药资产和技术专家队伍，爱美津致力于提供高品质产品、有竞争力的价格和无以匹敌的客户服务。 At the end of 2007, Amerigen has successfully completed the acquisition of an oral solid dose manufacturing facility in Suzhou Industrial Park, China and established Suzhou Amerigen Pharmaceutical Co., Ltd. 2007年底，爱美津完成了在中国苏州工业园区的口服固体制剂生产厂的收购，并成立了苏州爱美津制药有限公司。 The milestones of Suzhou Amerigen are as follows: 苏州爱美津制药的里程碑如下： 2007 Suzhou Amerigen was established 苏州爱美津成立 2008 First US regulatory filing 首次获得美国法规文件受理 2009 First US FDA PAI & General Inspection 首次美国食品药品监督管理局上市批准和常规检查 2010 Received US FDA approval for bulk tablet manufacturing 获得美国食品药品监督管理局的批准生产大包装片剂 2012 Passed CFDA Re-Inspection (GMP 2010 version) 通过中国食品药品监督管理局再次检查-新版GMP (2010版) 2013 Passed US FDA Inspection –Recommended approvals on four ANDAs 通过美国食品药品监督管理局检查- 4个简化新药被推荐批准 2014 Launched US Product and re-introduced China Products 产品在美国市场上市, 中国市场产品恢复生产。 2015 Passed US FDA Inspection on Data Integrity 通过美国食品药品监督管理局针对数据完整性的专项检查

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