Regulatory Affairs Specialist 注册专员
博赏管理咨询(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:2020-12-23
- 工作地点:上海-静安区
- 招聘人数:1人
- 工作经验:1年经验
- 学历要求:本科
- 职位月薪:0.7-1.3万/月
- 职位类别:生物工程/生物制药
职位描述
JOB FUNCTION-REQUIREMENTS:
This role will support new drug registration and drug variation submission to 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:
- Be familiar to Chinese regulation to support various development, manufacture, sales and marketing activities.
- Execute the registration strategy by preparing necessary documentation and communication under some supervision of line manager.
- Maintain existed products.
- Achieve the target timeline of submission and approval.
- Assist line manager managers to analyze regulatory scenarios by compiling and analyzing in-depth knowledge on the assigned products.
- Maintain good relationship with healthcare authorities.
- Work with internal and external clients to support the business of enterprise from regulatory aspect.
Competencies:
- Good communication and coordination skill
- Good analytical skill
- Earnest & Elaborative
- Proactive working attitude
- Excellent execution capacity
Qualifications and Experience:
- Above bachelor’s degree in science / Pharmaceutical Field
- At least 1 year experience of quality testing lab/manufacturing/Regulatory affairs
- Practiced skills on computer, English writing, and reading; basic speaking.
- Professional Knowledge/Skill:
- Professional knowledge on pharmaceutical
- Good understanding of drug regulations and technical requirement in China
公司介绍
Besins- healthcare是一家跨国制药企业,1885年由 Abel Besins先生在法国创立,目前总部位于比利时。拥有全资子公司Macanthy、Olympian实验室和Nutrico,影响力覆盖全球120多个国家,在美国,法国,德国,俄罗斯,黎巴嫩,泰国,中国香港设有办事处,工厂位于法国和比利时。
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,关爱人类的生命健康。
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,关爱人类的生命健康。
联系方式
- 公司地址:地址:span北京