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Regulatory Affairs Specialist/ Director

Status: Active
CompanyNeologics Bio
LocationSuzhou, China
Expiration2023-05-16
How to Apply

Please send your resume to: lin.chen@neologicsbio.com

Responsibilities 职责

 

  1. Make registration and declaration plan according to project schedule;

根据项目进度制定注册申报计划;

  1. Responsible for the company's new drug registration and application, including the integration, compilation and binding of new drug application materials;

负责公司项目新药注册申报,包括新药申报资料的整合、编写与装订;

  1. Provide support to r&d projects based on knowledge of registration regulations;

基于注册法规等相关知识,为研发项目提供支持;

  1. Responsible for the contact with the external organizations related to registration, such as CRO company and drug evaluation center, track the progress of registration, and timely coordinate and communicate with the relevant government departments;

负责与注册相关的外部机构如CRO公司、药物审评中心的联系,跟踪注册进度,及时与政府有关部门协调和沟通;

  1. Understand policies and regulations, drug registration policies and drug development trends, master and track the changes of registration regulations;了解政策法规、药品注册政策和药品发展动态,掌握和跟踪注册法规的变化;
  2. Complete other tasks assigned by superior

完成上级交代的其他事宜。

 

Qualifications 任职要求

 

  1. Bachelor degree or above, major in medicine, pharmacy or related本科及以上学历,医学、药学等相关专业;
  2. At least 3 years of new drug registration or clinical application experience, at least one IND application experience从事新药注册或临床申报工作三年以上,至少有一个IND项目申报经验;
  3. Experience in clinical application of new biologic drugs and Chinese and American double application is preferred有生物药新药临床申报经验和中美双报经验优先;
  4. Familiar with the process of drug registration and application, and be able to write application materials熟悉药品注册申报各个流程,并能撰写申报材料;
  5. Familiar with drug registration laws and regulations and technical guidelines熟悉药品注册法律法规和技术指导原则;
  6. Good English reading and writing skills, be able to search and read literatures related to new drug development at home and abroad有良好的英文读写能力,能熟练的查找、阅读国内外新药研发相关文献;
  7. Have strong literature searching ability, communication and coordination ability, keep good communication with related departments具有较强的文献检索能力,沟通及协调能力,与相关部门保持良好沟通。
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