法规注册主管
深圳碳云智能科技有限公司
- 公司规模:50-150人
- 公司性质:民营公司
- 公司行业:医疗/护理/卫生 互联网/电子商务
职位信息
- 发布日期:2016-12-06
- 工作地点:深圳-南山区
- 招聘人数:1人
- 职位月薪:10000-14999/月
- 职位类别:药品注册
职位描述
职位描述:
Responsibilities:
1. Prepare the regulatory submissions for registration of new products where required.
2. Maintain contact with regulatory officials to determine regulatory requirements, ensure compliance with said regulations, and expedite approvals.
3. Maintain, update, and archive the submission sets together with approved product documents (labeling, specification and test procedures) in accordance with relevant regulations and company SOPs.
4. Maintain an up-to-date knowledgebase to ensure prompt and professional responses to queries relating to company products and provide regulatory advice as required.
5. Cooperate with relevant regulatory departments and agencies to prepare related documents for import license applications as it pertains to the customs clearance of samples and reference standards for registration purposes.
6. Conduct any other related duties as required.
Qualifications:
1. Bachelor degree or higher in Biology, Pharmacy, Chemistry, Medical or a related discipline.
2. Previous experience with the CFDA preferred.
3. A minimum of 5 years working experience in Product Registration.
4. Experience in biological and medical products registration and import is preferred.
5. Excellent organizational skills with an eye for detail and the ability to prioritize.
6. Ability to take initiative as well as function as part of a team.
7. Fluency in both written and spoken English is preferred.
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Responsibilities:
1. Prepare the regulatory submissions for registration of new products where required.
2. Maintain contact with regulatory officials to determine regulatory requirements, ensure compliance with said regulations, and expedite approvals.
3. Maintain, update, and archive the submission sets together with approved product documents (labeling, specification and test procedures) in accordance with relevant regulations and company SOPs.
4. Maintain an up-to-date knowledgebase to ensure prompt and professional responses to queries relating to company products and provide regulatory advice as required.
5. Cooperate with relevant regulatory departments and agencies to prepare related documents for import license applications as it pertains to the customs clearance of samples and reference standards for registration purposes.
6. Conduct any other related duties as required.
Qualifications:
1. Bachelor degree or higher in Biology, Pharmacy, Chemistry, Medical or a related discipline.
2. Previous experience with the CFDA preferred.
3. A minimum of 5 years working experience in Product Registration.
4. Experience in biological and medical products registration and import is preferred.
5. Excellent organizational skills with an eye for detail and the ability to prioritize.
6. Ability to take initiative as well as function as part of a team.
7. Fluency in both written and spoken English is preferred.
职能类别: 药品注册
公司介绍
公司概述
深圳碳云智能科技有限公司成立于2015年10月,围绕消费者的生命大数据、互联网和人工智能创建数字生命的生态系统。公司主要创始团队由全球顶尖生物科技专家组成,在组学技术、移动医疗、医疗服务、生物数据分析、人工智能和数据挖掘等领域有丰富的经验。基于全球专业度最高、指数增长的数字生命网络,我们致力同世界领先的合作伙伴一起,去解读、研究、引导和管理数字生命,提供个性化管理数字生命的产品和服务,创建数字健康新生活。
主营业务
将基于全球专业度最高、指数增长的全息全程健康医疗大数据,通过顶尖的数据挖掘和机器分析技术,提供私人专享的健康指数分析和预测。将与全球尖端合作伙伴一起,从生命初始,全程关注,全息洞察,全面呵护您的健康。已有多家机构与碳云智能有合作意向,其中包括研究机构,药厂,体检中心,医院,诊断公司,保险公司,健康管理公司等。
核心竞争力
中国首个专业度最高的百万健康数据收集平台,结合中国最强的生物科技和人工智能领军团队,通过数据挖掘和机器学习,将人工智能的优势带入海量的生命大数据分析和应用中。通过不断迭代和更新知识库,优化后的算法将培育出第一个全面管理生命健康的智能机器人,全程呵护每个人的健康,时时刻刻给予健康生活的点点滴滴建议。
深圳碳云智能科技有限公司成立于2015年10月,围绕消费者的生命大数据、互联网和人工智能创建数字生命的生态系统。公司主要创始团队由全球顶尖生物科技专家组成,在组学技术、移动医疗、医疗服务、生物数据分析、人工智能和数据挖掘等领域有丰富的经验。基于全球专业度最高、指数增长的数字生命网络,我们致力同世界领先的合作伙伴一起,去解读、研究、引导和管理数字生命,提供个性化管理数字生命的产品和服务,创建数字健康新生活。
主营业务
将基于全球专业度最高、指数增长的全息全程健康医疗大数据,通过顶尖的数据挖掘和机器分析技术,提供私人专享的健康指数分析和预测。将与全球尖端合作伙伴一起,从生命初始,全程关注,全息洞察,全面呵护您的健康。已有多家机构与碳云智能有合作意向,其中包括研究机构,药厂,体检中心,医院,诊断公司,保险公司,健康管理公司等。
核心竞争力
中国首个专业度最高的百万健康数据收集平台,结合中国最强的生物科技和人工智能领军团队,通过数据挖掘和机器学习,将人工智能的优势带入海量的生命大数据分析和应用中。通过不断迭代和更新知识库,优化后的算法将培育出第一个全面管理生命健康的智能机器人,全程呵护每个人的健康,时时刻刻给予健康生活的点点滴滴建议。
联系方式
- Email:huangsisi@icarbonx.com
- 公司地址:上班地址:苏州