长沙招聘

职 责：
Position Overview
Assist supervisor to maintain product licenses including license renewals, labeling updates and other supplementary applications. Supports other Regulatory Affairs staff to compile CTA or NDA dossiers and prepare for evaluation meetings, if necessary.
Responsibilities
1. Assist getting approvals of license renewals, labeling updates and other supplementary applications within the company budget and timeframe. This includes the following steps:
? Contact headquarter for the registration of materials such as certificates, dossiers, samples and other related documents.
? Translate, double check and edit application documents for submission to SFDA.
? Liaise with government authorities to follow up the schedule for evaluation, quality assessment etc.

2. Assist obtaining QC test results from appropriate local testing institute by implementing the following actions:
? Assist to provide sample and other related stuff or documents;
? Follow up test;
? Communicate with technicians for the status of QC tests;
? Coordinate and cooperate with the expert in charge of testing to speed up the release process.
3. Support other Regulatory Affairs staff to compile CTA or NDA dossiers and prepare for evaluation meetings, if necessary. This includes the following steps:
? Translate, double check and edit application documents for submission to SFDA.
? Assist to compile the dossier.
? Provide administrative assistance to the evaluation meeting besides dossier preparation assistance if necessary.

4. Coordinate with other departments during the registration process to share necessary information for registration.
5. Update SFDA/CDE news and share internally.
6. Be familiar with internal database in the daily work.
7. Archive electronic documents and hard copy for responsible products following local SOPs.

要 求：
服务担当技能要求/ Skills and qualifications required:

Formal Education/Training
? University degree (B.A., B.S., M.S.) or equivalent is required; specialization in pharmacy, pharmacology, chemistry, medicine, engineering or the biological sciences is preferred.
? Fluent in Mandarin Chinese; high ability in English.

Experience
? No specific working experience is required. At least 1 year working experience is preferred.

Knowledge, Skills, and Abilities
? Careful planning to achieve accurate and timely results.
? Work precisely according to procedures, rules and regulations.
? Recognize recurring issues and analyze their causes in order to reach a solution.
? Good ability of learning. Become familiar with the products and regulations in short time.
? Good verbal and written communication skills.
? Good computer skills in Windows Office software, including Word, Excel, PowerPoint, etc.
? Ethic, enthusiastic, positive, careful and cautious work attitude.

中智上海经济技术合作有限公司（简称中智上海公司）是中智全国性服务网络战略布局中重要的战略成员。目前，中智上海公司服务2万余家客户企业，雇员数达77万。公司主营业务包含：人力资源外包、招聘+业务外包、国际业务、培训业务和贸易服务五大板块。2013年，中智上海公司荣获由上海市政府颁发的“上海市质量金奖”。2016年，公司荣获由国家质检总局颁发的第二届“中国质量奖”提名奖。2018年，中智上海公司第一批获得由上海品牌国际认证联盟颁发的“上海品牌”荣誉。中智上海公司秉承“诚信、尊重、公正、专业”的服务精神，积极践行社会责任，不断追求卓越，持续为客户和雇员创造价值。
应聘者请发简历至 resume@ciicsh.com