Regulatory Affairs Manager
西班牙金武制药公司
- 公司规模：50-150人
- 公司行业：制药/生物工程
职位信息
- 发布日期：2014-05-16
- 工作地点：上海
- 招聘人数：若干
- 工作经验：五年以上
- 学历要求：本科
- 语言要求：英语精通
- 职位月薪：面议
- 职位类别：药品注册 医疗器械注册
职位描述
RESPONSIBILITIES:
1. Product import licence applications for the imported new products, PIL renewals for existing imported products and local product registrations of other biological, API and chemical drugs
(1)Management of complete and timely dossier preparation/submission and/or supplementary applications for the new imported products, local biological, API and chemical drugs
(2)Close contacts with registration departments within HQs and other partners/CROs for product related information
(3)Management of filing/updating registration dossiers for existing products
(4)Maintenance of relationships with internal and external registration partners
(5)Guarantee of effective collaboration with local registration/health authorities
2. Other regulatory affairs deparment management responsibilities
(1)Timely updating to the managing director on the latest regulatory affairs status as well as all possible changes regarding registration procedures of Chinese authorities
(2)Provide regulatory strategies and supports for new product development and launch plan
(3)Build-up and maintenance of an extensive network with key health authorities, especially registration officials
(4)Ensure close working relationships with marketing/medical & sales and GA/PR team members
Qualifications:
1. University above degrees in Pharmacology/Medical/biochemistry disciplines
2. Track record regulatory affairs management experiences in the MNC pharmaceuticals industry
3. Maintain long term good working relationships with related health authorities and KOLs
4. Drug registration related crisis management experiences
5. Strong communication and influencing skills
6. People management skills
7. English language efficiency
1. Product import licence applications for the imported new products, PIL renewals for existing imported products and local product registrations of other biological, API and chemical drugs
(1)Management of complete and timely dossier preparation/submission and/or supplementary applications for the new imported products, local biological, API and chemical drugs
(2)Close contacts with registration departments within HQs and other partners/CROs for product related information
(3)Management of filing/updating registration dossiers for existing products
(4)Maintenance of relationships with internal and external registration partners
(5)Guarantee of effective collaboration with local registration/health authorities
2. Other regulatory affairs deparment management responsibilities
(1)Timely updating to the managing director on the latest regulatory affairs status as well as all possible changes regarding registration procedures of Chinese authorities
(2)Provide regulatory strategies and supports for new product development and launch plan
(3)Build-up and maintenance of an extensive network with key health authorities, especially registration officials
(4)Ensure close working relationships with marketing/medical & sales and GA/PR team members
Qualifications:
1. University above degrees in Pharmacology/Medical/biochemistry disciplines
2. Track record regulatory affairs management experiences in the MNC pharmaceuticals industry
3. Maintain long term good working relationships with related health authorities and KOLs
4. Drug registration related crisis management experiences
5. Strong communication and influencing skills
6. People management skills
7. English language efficiency
公司介绍
金武集团是世界知名的跨国性企业，在成品药的研发及生产、原料药的研发和生产、原料贸易和医药商业等领域卓有建树。公司具有强大的实力和深厚的专业背景，在欧洲、美洲、亚洲、非洲等地，都分布着金武旗下的子公司和合资公司，2006年公司的销售额达到了25亿欧元。
金武集团在中国的代表处设在上海。2006年金武集团在中国的投资总额高达10亿人民币，集团在中国上海及浙江投资了世界一流的生产基地。
我们的目标是成为行业的领头羊。
深厚的医学背景，服务全球的专业经验，让我们成为您可以信赖的合作伙伴。我们在多个领域里提供着专业的产品和服务，特别是在抗生素、消化系统、呼吸系统和妇科产品领域，具有独特的优势。同时，我们汇集了行业内优秀的专业精英人才，提供专家级的服务。
快速反应，有效运作。
优质服务，洞察所需。
互相尊重，融洽协作。
全心以赴，承诺未来。
请招聘人员发简历的时候发到本公司。
金武集团在中国的代表处设在上海。2006年金武集团在中国的投资总额高达10亿人民币，集团在中国上海及浙江投资了世界一流的生产基地。
我们的目标是成为行业的领头羊。
深厚的医学背景，服务全球的专业经验，让我们成为您可以信赖的合作伙伴。我们在多个领域里提供着专业的产品和服务，特别是在抗生素、消化系统、呼吸系统和妇科产品领域，具有独特的优势。同时，我们汇集了行业内优秀的专业精英人才，提供专家级的服务。
快速反应，有效运作。
优质服务，洞察所需。
互相尊重，融洽协作。
全心以赴，承诺未来。
请招聘人员发简历的时候发到本公司。