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Regulatory Affairs Specialist

面议

北京-丰台区

|

2年以上经验

|

统招本科

职位诱惑:带薪年假,定期体检,五险一金,上市公司,领导好,发展空间大
应聘职位

西氏医药包装(中国)有限公司

制药/生物工程  | 100-499人

凯旋北路1188号B座17G查看地图

职位描述

Position Summary:



This role is responsible for coordinating and authoring regulatory submissions for West’s products and processes. Address customer regulatory requests and maintain knowledge of current US and international regulations/guidelines/policies applicable to West’s products and services.






Responsibilities:



Complete structured regulatory assignments with guidance in support of R&D and commercial programs with a focus on authoring, maintenance and tracking of China dossiers for submission to NMPA [Dossiers, LOAs], customer requests, etc. in compliance with regulations, guidelines and procedures.

Support project development teams and communicate regulatory progress, decisions, strategies, etc., with guidance.

Review assigned technical project documentation, certifications, correspondences, and external communications, as needed.

Provide assistance with customer regulatory requests, including regulatory letters, compliance questionnaires, LOAs (Letters of Authorization/Access).

Support in strengthening the existing contacts and establishing new contacts with NMPA officials in Beijing, Shanghai and other provinces for pharmaceutical packaging.

Develop specific objectives and manage work assignments, with guidance, in an effort to achieve personal objectives in conformance with overall business goals.

Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.

Challenge processes, remain open to ideas and changes to continuously improve and seek better alternatives and drive change.

Adhere to all applicable government and West regulations, practices and procedures to maintain compliance.

Clearly and effectively communicate team/project progress/status, decisions, timelines, etc.

Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Project, MS PowerPoint, Adobe, SharePoint and LOA request system, eCTD and others as required.






Requirements:



Bachelor's or Master’s in related discipline.

1-3 years pharmaceutical industry experience

Knowledge of Project Management

Knowledge of CMC regulatory affairs and regulatory operations including sterile pharmaceutical products produced by aseptic processing, direct interactions with regulatory agencies and management of regulatory support systems is a plus.

Ability to read, write and speak English

10% - 15% travelling (Projects, Meetings, Training)

岗位要求

  • 不限
  • 不限
  • Commercial
  • 0人

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