Regulatory Affairs Manager
大昌华嘉商业(中国)有限公司 - 医药保健部
- 公司规模:500-1000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2012-09-07
- 工作地点:北京
- 招聘人数:1
- 工作经验:五年以上
- 学历要求:本科
- 职位类别:药品注册
职位描述
Job Description:
1. Make feasibility analysis and design the drug registration strategy
2. Filing all documents to SFDA and local authorities with good quality and according to the registration strategy.
3. Preparing and submitting drug registration application and dossier, follow up evaluation approval procedure, obtain license independently
4. Updating product information includes production information, quality control information, shelf life, information in package materials and etc. according to the information from manufacturers or SFDA
5. Setting up and maintaining good relationship with KOLs and health authorities
6. Monitoring regulatory policy on drug
7. Providing updated regulation & policy information to support the business lines
8. To well coordinate with internal & external customers
Job Requirements:
1. Bachelor or above degree of pharmacy, medical, chemistry or relatives
2. At least 5 years registration experience is required
3. Well understand registration policies and procedure of drug
4. Familiar to write registration dossier and registration process
5. Good oral and written English
6. Good skill on computer
7. Good Inter-personal & communication skill
8. Good project management skill
1. Make feasibility analysis and design the drug registration strategy
2. Filing all documents to SFDA and local authorities with good quality and according to the registration strategy.
3. Preparing and submitting drug registration application and dossier, follow up evaluation approval procedure, obtain license independently
4. Updating product information includes production information, quality control information, shelf life, information in package materials and etc. according to the information from manufacturers or SFDA
5. Setting up and maintaining good relationship with KOLs and health authorities
6. Monitoring regulatory policy on drug
7. Providing updated regulation & policy information to support the business lines
8. To well coordinate with internal & external customers
Job Requirements:
1. Bachelor or above degree of pharmacy, medical, chemistry or relatives
2. At least 5 years registration experience is required
3. Well understand registration policies and procedure of drug
4. Familiar to write registration dossier and registration process
5. Good oral and written English
6. Good skill on computer
7. Good Inter-personal & communication skill
8. Good project management skill
公司介绍
DKSH Business Unit Healthcare is the leading Market Expansion Services provider for healthcare companies seeking to grow their business in Asia. Custom-made offerings comprise registration and market entry studies as well as importation, customs clearance, marketing and sales to physical distribution, invoicing and cash collection. Products available through DKSH Healthcare include ethical pharmaceuticals, consumer health, over-the-counter (OTC), as well as medical devices. With 150 business locations in 14 countries and around 9,200 specialized staff, Business Unit Healthcare serves over 150,000 customers and generated net sales of around CHF 4.544 billion in 2014.
大昌华嘉医药保健部是领先的为药品,非处方药(OTC),保健消费品及医疗器械产品的公司提供市场拓展服务的专家,提供涵盖产品注册、进口、生产、市场推广和销售、物流及售后服务的全面完整的服务项目。医药保健业务单元分布于全球14个国家150个营业网点,拥有9,200位专业员工。2014年 ,医药保健部为超过150, 000位客户提供服务,并取得净销售额45.44亿瑞士法郎的业绩表现。
大昌华嘉医药保健部是领先的为药品,非处方药(OTC),保健消费品及医疗器械产品的公司提供市场拓展服务的专家,提供涵盖产品注册、进口、生产、市场推广和销售、物流及售后服务的全面完整的服务项目。医药保健业务单元分布于全球14个国家150个营业网点,拥有9,200位专业员工。2014年 ,医药保健部为超过150, 000位客户提供服务,并取得净销售额45.44亿瑞士法郎的业绩表现。
联系方式
- 公司地址:地址:span北京市朝阳区光华路7号汉威大厦