Assistant Regulatory Affairs Manager/RA Supervisor
博赏医药咨询(上海)有限公司
- 公司规模:150-500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:2014-07-31
- 工作地点:上海
- 招聘人数:1
- 学历要求:本科
- 职位月薪:面议
- 职位类别:药品注册
职位描述
This role will support new drug registration and ensure regulatory activity of enterprise be executed smoothly; Work with internal and external clients to support the business of enterprise from regulatory aspect; Maintain good relationship with healthcare authorities.
Duties & Responsibilities:
1.Acquire comprehensive knowledge of Chinese regulation to support various development, manufacture, sales and marketing activities.
2.Execute the registration strategy by preparing necessary documentation and communication under some supervision of line manager.
3.Develop approaches to new drug registration.
4.Maintain existed products.
5.Achieve the target timeline of submission and approval.
6.Assist line manager managers to analyze regulatory scenarios by compiling and analyzing in-depth knowledge on the assigned products.
7.Maintain good relationship with healthcare authorities.
8.Work with internal and external clients to support the business of enterprise from regulatory aspect.
Competencies:
1.Good communication and coordination skill
2.Good analytical skill
3.Earnest & Elaborative
4.Proactive working attitude
5.Excellent execution capacity
Qualifications and Experience:
1.Above Bachelor Degree in Science / Medical / Pharmaceutical Field
2.At least 3 years working experience of new products development and product registration
3.Practiced skills on computer, good at English writing, and reading; basic speaking.
4.Professional Knowledge/Skill:
§ Professional knowledge on pharmaceutical
§ Good understanding of drug regulations and technical requirement in China
A Franco-Belgian Global Pharmaceutical company founded in 1885 and offices globally. Specialized in the development and worldwide commercialization of innovative treatments for the well-being of men and women throughout their lives, we have established a strong reputation in the fields of endocrinology, obstetrics & gynecology and are a world renowned player in hormonal therapies for both women and men.
What's on offer?
Besins will offers excellent package that incorporate competitive salary, benefit and stimulating performance bonus; As the business structure is flat, company culture is open and transparent, therefore, these offers every employee broad development space.
公司介绍
Besins- healthcare是激素和透皮给药领域的先锋,致力于开发和在全球推广创新药物,关爱女性和男性的生命健康。
联系方式
- 公司地址:上班地址:长寿路1111号悦达889广场