Senior Regulatory Affair Specialist (Contractor)

北京市 灵活 RMB20,000 - RMB25,000 月薪 (RMB240,000 - RMB300,000 年薪) View Job Description
Prefer candidates with 2-3 year experiences in regulatory affairs.
  • Promising and booming business
  • Oversees lifecycle management of products cross APAC

关于我们的客户

The company is a global, research-driven biopharmaceutical company, focused on advancing innovative therapies for serious diseases. The JAPAC team is looking for a senior regulatory affair specialist to support the implementation of business strategies.

职责描述

  • Manage the lifecycle activities of device-related products within assigned projects to ensure regulatory compliance.
  • Support regulatory assessments and activities, including variations, for assigned projects.
  • Collaborate with global regulatory teams to implement regulatory strategies aligned with commercial priorities for the JAPAC region.
  • Represent the regulatory affairs function at cross-functional meetings (e.g., commercial, R&D, CMC) and provide regulatory insights for product registration.
  • Work with JAPAC cross-functional teams and commercial teams to meet business objectives.
  • Ensure regulatory compliance for all assigned assets/products and implement corrective actions when necessary.
  • Contribute to regulatory initiatives and strategies for the JAPAC area.

理想的求职者

  • Bachelor's degree in Pharmacy, Pharmacology, Bioengineering, or a related field.
  • Minimum of 5 years' experience in Regulatory Affairs, preferably within the JAPAC region.
  • In-depth understanding of regulatory requirements in China.
  • Proven interpersonal skills and the ability to communicate complex regulatory issues effectively.

薪酬待遇

  • Work on exciting projects in a fast-paced, global environment
  • Stable plaform and fast-growing business
  • Long-term role start from 1-year contractor
联系
Hao Zheng
职位编号
JN-122024-6610007
联系电话
+86 10 5969 0622

职位概要

职位类别
生命科学
子类别
法规事务
行业
医疗保健/制药
地区
北京市
工作类型
灵活
顾问名字
Hao Zheng
顾问电话号码
+86 10 5969 0622
职位编号
JN-122024-6610007

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