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Registration Officer

 
岗位信息
  • 更新时间:2016-02-29
  • 学历:本科
  • 工作地点:北京市
  • 语言要求:英语
  • 工作年限:1年以下
  • 招聘人数:1
  • 月薪:0-0元
  • 性质:
岗位要求
岗位职责:



JOB SUMMARY

The Registration Officer 〔RO) assists with the regulatory maintenance of a portfolio of products. This includes the preparation of regulatory submissions to the Chinese authorities for registration of new products, variations to marketed products and clinical trial notifications, when required. RO will assist the Registration Managers on specific projects, and in some instances will be responsible for their own projects. The RO ensures that each project operates within the set timeframes, is conducted to the highest standards of quality and is in accordance with local and international regulatory agency requirements and Standard Operating Procedures. The RO may also be required to assist on special projects for WRSEM-China.


RESPONSIBILITIES

·Assist in the preparation of applications for registration of new products, variations to marketed products and clinical trial applications, where required

·Assist with responses to deficiency letters and other requests for data from regulatory agencies

·Assist in the preparation and monitoring of specification validation test for the registration of new products and relevant variations.

·Review labeling, product information, consumer medicine information for compliance with relevant regulations and codes

·Review and prepare applications for change

·Prepare rescheduling applications, as required

·Maintain an up to date knowledge of the relevant legislation in China relating to therapeutic goods

·Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to company products

·Provide regulatory advice to company personnel as required

·Maintain regulatory documentation in line with Pfizer Procedures

·Maintain contact with officials of the FDA, and industry associations through attendance at meetings, conferences and seminars as appropriate

·Attend regular departmental meetings with manger/supervisor to build in continuous feedback mechanisms

·May be required to participate on special projects for WRSEM-China

EDUCATION & EXPERIENCE REQUIREMENTS

·Tertiary qualifications in pharmacy or a science degree with a pharmacology major

·Good working knowledge of international and local regulatory guidelines and codes

·Proficiency in Basic Microsoft Word, PowerPoint and Excel

·Good communication & interpersonal skills

·Good Teamwork/collaboration

·Able to work under pressure in a busy environment

·Good working knowledge of Microsoft Word, PowerPoint and Excel

·Good English reading skill

·Ability to integrate data, summarize and communicate at point of service

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