Manager, Regulatory Affairs, Pharmaceutical(职位编号:09400)
巴斯夫(中国)有限公司北京分公司
- 公司规模:500-1000人
- 公司性质:外资(欧美)
- 公司行业:石油/化工/矿产/地质
职位信息
- 发布日期:2014-04-30
- 工作地点:北京-朝阳区
- 招聘人数:1
- 工作经验:五年以上
- 学历要求:本科
- 语言要求:英语熟练
- 职位月薪:面议
- 职位类别:药品注册 其他
职位描述
Work Location: Beijing
Reporting to: Senior Manager
People Management Responsibility: No
Travel Required: Yes
Shift Required: No
JOB OBJECTIVES:
Ensure regulatory compliance, achieving and maintaining the registration of nutritional and food performance ingredients in CHINA through the application of entrepreneurial principles. For this task, this person is in close cooperation with the regional regulatory team.
1. To proceed IDL application to support business compliance and development of SBU
2. To provide regulatory advice and updates to customers and sales team with the objective to
3. To meet customers’ regulatory requirements and support SBU business development.
4. To be responsible for professional & effective communication with government and BASF global
5. Regulatory team for compliance / revise / updates regulations
MAIN RESPONSIBILITIES:
1. Key person in ensuring the regulatory and legal compliance of the Pharma product portfolio in CHINA, including active monitoring of the regulatory developments in CHINA. The results of this monitoring have to be collected, analysed for relevance and recommendations to be given to regional/global regulatory team.
2. Provide regular regulatory Information /registration updates to supervisor to enable strategic decision making on existing and pipeline ENP products
3. Pharma Industry Regulatory Intelligence Collect industry Information & published data, including industry Associations/Groups participation and activies update
4. Actively facilitate and co-ordinate regulatory lobbying by working with Govt relations dept to
5. Lobby the relevant govt dept & agencies for special projects/ products.
6. Monitoring Excipient regulations by working with industry groups or association
7. e.g. IPEC on CDMF to lobby SFDA/MoH etc.
8. Work closely with technical team in terms of specification set up & technical evaluation method related topic.
REQUIREMENTS:
1. University degree, post-graduate major in Pharmacy/ Medical science /Chemistry
2. No less than 5- year experience of regulatory affairs in pharmaceutical / medical industry
3. Solid experience and knowledge of pharmaceutical related regulation , working procedure as well as contacts in the industry
4. Fluent oral & written with English.
Reporting to: Senior Manager
People Management Responsibility: No
Travel Required: Yes
Shift Required: No
JOB OBJECTIVES:
Ensure regulatory compliance, achieving and maintaining the registration of nutritional and food performance ingredients in CHINA through the application of entrepreneurial principles. For this task, this person is in close cooperation with the regional regulatory team.
1. To proceed IDL application to support business compliance and development of SBU
2. To provide regulatory advice and updates to customers and sales team with the objective to
3. To meet customers’ regulatory requirements and support SBU business development.
4. To be responsible for professional & effective communication with government and BASF global
5. Regulatory team for compliance / revise / updates regulations
MAIN RESPONSIBILITIES:
1. Key person in ensuring the regulatory and legal compliance of the Pharma product portfolio in CHINA, including active monitoring of the regulatory developments in CHINA. The results of this monitoring have to be collected, analysed for relevance and recommendations to be given to regional/global regulatory team.
2. Provide regular regulatory Information /registration updates to supervisor to enable strategic decision making on existing and pipeline ENP products
3. Pharma Industry Regulatory Intelligence Collect industry Information & published data, including industry Associations/Groups participation and activies update
4. Actively facilitate and co-ordinate regulatory lobbying by working with Govt relations dept to
5. Lobby the relevant govt dept & agencies for special projects/ products.
6. Monitoring Excipient regulations by working with industry groups or association
7. e.g. IPEC on CDMF to lobby SFDA/MoH etc.
8. Work closely with technical team in terms of specification set up & technical evaluation method related topic.
REQUIREMENTS:
1. University degree, post-graduate major in Pharmacy/ Medical science /Chemistry
2. No less than 5- year experience of regulatory affairs in pharmaceutical / medical industry
3. Solid experience and knowledge of pharmaceutical related regulation , working procedure as well as contacts in the industry
4. Fluent oral & written with English.
公司介绍
关于巴斯夫
巴斯夫是全球领先的化工公司:The Chemical Company。公司的产品范围包括从化学品、塑料、特性产品、农用产品到原油和天然气。作为值得信赖的合作伙伴,巴斯夫帮助各行各业的客户取得更大成功。通过提供高价值产品和智能解决方案,巴斯夫在应对全球面临的问题中扮演重要角色,如气候保护、能源效率、营养以及交通运输与移动通讯领域等。巴斯夫2010年全球销售额约639亿欧元,截至2010年底员工约109,000名。若想获得更多关于巴斯夫的信息,请访问: www.basf.com。
关于巴斯夫大中华区
巴斯夫与大中华市场的渊源可以追溯到1885年,从那时起巴斯夫就是中国的忠实合作伙伴。它是中国化工领域最大的外国投资商之一。2010年,公司在大中华区员工人数约6,980名,销售额约58亿欧元,拥有26个巴斯夫全资子公司和14个巴斯夫合资公司。欲了解更多信息,请登陆www.greater-china.basf.com。
联 系 人: 人力资源部
联系地址: 上海市西藏中路18号
邮政编码: 200001
咨询信箱: hr-china@basf.com (此信箱不接受职位申请,敬请登陆www.greater-china.basf.com/careers进行在线申请。)
公司主页: http://www.basf.com / http://www.greater-china.basf.com
巴斯夫是全球领先的化工公司:The Chemical Company。公司的产品范围包括从化学品、塑料、特性产品、农用产品到原油和天然气。作为值得信赖的合作伙伴,巴斯夫帮助各行各业的客户取得更大成功。通过提供高价值产品和智能解决方案,巴斯夫在应对全球面临的问题中扮演重要角色,如气候保护、能源效率、营养以及交通运输与移动通讯领域等。巴斯夫2010年全球销售额约639亿欧元,截至2010年底员工约109,000名。若想获得更多关于巴斯夫的信息,请访问: www.basf.com。
关于巴斯夫大中华区
巴斯夫与大中华市场的渊源可以追溯到1885年,从那时起巴斯夫就是中国的忠实合作伙伴。它是中国化工领域最大的外国投资商之一。2010年,公司在大中华区员工人数约6,980名,销售额约58亿欧元,拥有26个巴斯夫全资子公司和14个巴斯夫合资公司。欲了解更多信息,请登陆www.greater-china.basf.com。
联 系 人: 人力资源部
联系地址: 上海市西藏中路18号
邮政编码: 200001
咨询信箱: hr-china@basf.com (此信箱不接受职位申请,敬请登陆www.greater-china.basf.com/careers进行在线申请。)
公司主页: http://www.basf.com / http://www.greater-china.basf.com
联系方式
- 公司网站:http://www.basf.com
- Email:hr-china@basf.com
- 公司地址:北京市朝阳区麦子店街37号
- 邮政编码:100125
- 联系人:人力资源部