职位描述
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Position Information:
1.Develop an annual registration plan based on Southeast Asia, EU, Middle East, and Western market regulations and trends, clarify quality objectives, and drive product registration with advanced project management to help the company expand into international markets.
2.Evaluate market access for target markets, lead product registration applications, and enhance the team's proficiency in the aforementioned market regulations through training.
3.Review registration varieties and SOP documents, optimize documents in line with target market regulatory dynamics, and ensure company operations are compliant.
4.Coordinate the entire process of domestic and international drug materials, accurately translate and proofread international submission documents, and efficiently communicate with target market officials to advance the registration process.
5.Track target market pharmaceutical regulations and guidelines, organize analysis, and transform them into strategic recommendations for the company to aid decision-making.
6.Assist with domestic and international quality audits, complete on-site translation, and translation of rectification reports, etc.
7.Collaborate with R
工作地点
地址:深圳坪山区深圳深圳市坪山区坑梓街道金辉路11号 健康元海滨药业有限公司


职位发布者
张达翔HR
健康元药业集团股份有限公司

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制药·生物工程
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100-199人
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私营·民营企业
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重庆南岸