上海 [切换城市] 上海招聘上海生物/制药/医疗器械招聘上海生物工程/生物制药招聘

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:

  1. Be familiar to 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. Maintain existed products.
  4. Achieve the target timeline of submission and approval.
  5. Assist line manager managers to analyze regulatory scenarios by compiling and analyzing in-depth knowledge on the assigned products.
  6. Maintain good relationship with healthcare authorities.
  7. 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’s degree in science / Pharmaceutical Field
  2. At least 1 year experience of quality testing lab/manufacturing/Regulatory affairs
  3. Practiced skills on computer, English writing, and reading; basic speaking.
  4. Professional Knowledge/Skill:
  • Professional knowledge on pharmaceutical
  • Good understanding of drug regulations and technical requirement in China

职能类别:生物工程/生物制药

关键字:药学,注册,cmc

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。

联系方式

  • 公司地址:地址:span北京