宜昌招聘

职位描述：
Position Summary
? Participant in registration strategy discussion and responsible for implementation of the planned registration action
? Compliance with applicable policies, procedures and other regulations

Duties and Responsibilities
I: Regulatory
? Be fully responsible for the registration dossier preparation and submission of assigned projects;
? Be responsible for timely order the registration sample, dossier, certificates…;
? Contribute to the discussion of registration plan with both local and global team;
? Achieve the target timeline of submission and approval;
? Track the registration status in CDE and CFDA and timely report to the line manager;
? Organize to answer technical questions referred by HAs;
? Coordinate of F2F discussion meeting with HAs;
? Communicate with HQ about the issues related to the responsible product registration; for example dealing with relative issues on drug quality test in HA’s lab;
? Accountable for ensuring regulatory compliance for the responsible brands like License renewal, CMC, PI etc;
? Monitor regulatory changes and report to line manager timely
? Provide regulatory support for other functions (marketing, commercial, medical etc);
? Ensure regulatory activities comply with Chiesi internal SOP for routine work

II: Other tasks
? Responsible for Quality Assurance (QA) activities in local level, including collect/archive the relevant of Manufacture/Quality information, and handle product issue & quality case in timely, and establish and maintenance of QA SOP. (if applicable)
? Provide regulatory support for ongoing clinical trials, eg clinical trial registration, annual report etc (if applicable)
? Fulfil other tasks assigned by the Line Manager.

Qualifications (Knowledge, Ability, and Skill Requirements)
? Bachelor or above degree in Life Sciences, Pharmacy or Medicine, or equivalent experience
? Above 2 years working experience in regulatory affairs;
? Familiar with drug production, chemistry and analysis;
? Familiar with products registration approval application procedures and related regulations and laws;
? Ability to read, analyze professional information and write professional articles;
? Ability to solve problems independently;
? Be good at communication, organization and coordination;
? Good interpersonal skills and negotiation skills;
? Fluency in spoken and written English.
? Prior working experience in Health authority is preferred. 举报 分享

凯西制药公司总部位于意大利帕尔马市，全球有超过4500名员工。公司业务覆盖全球市场，在全球25个国家建立了分公司并在很多地区拥有合作伙伴，2015年集团销售额已超14.6亿欧元。三个主要研发中心位于意大利、法国和美国，每年用于新药研发的费用为销售额的20％，有300多名员工专业从事研发工作。更多相关信息请访问凯西制药公司官方网站*************************