注册专员

Hiring By - Biostaffic

 BioPharma

China

Job Highlights

Not Disclosed

Posted 4 months ago
Job details
职位来源于智联招聘。
1、负责注册资料eCTD制作,资料报送、递交、进度跟进,及时解决或完整传达审评过程中的问题;
2、协调相关部门准备注册现场核查资料,组织模拟现场核查(包括药学、非临床及临床),跟踪缺陷项按法规要求完成整改。跟踪协调正式现场核查,确保核查顺利完成。
3、根据公司整体发展策略,结合项目进度,拟定注册计划。组织协调相关部门按计划提供注册申报资料,对研究内容和原始资料进行基本审核并提出初步意见,及时提出注册申报风险,沟通处理方案,确保符合各项政策/法规/指导原则的要求;
4、制定内审计划,组织完成注册资料内审工作;
5、根据注册计划,对项目的研究开发和注册进度把关,协调、反馈处理项目开展中的注册风险问题,提供必要的法规支持工作;
6、负责收集、汇总、掌握注册相关政策/法规/指导原则动态信息,了解同类品种产品开发动态及失败经验,并定期向注册部或相关职能部门提供相关信息,为项目研究开发提供合规性建议;
7、维护公司信息安全,保守公司机密。
8、完成上级交办的其他工作。
岗位要求:
1、药事法规、生物/生命科学、药学、医学等相关专业本科及以上。
2、一年以上相关注册工作经验,或有同类生物制品公司研发、QC、QA经验三年或以上,有意向从事注册工作。
3、熟悉药品注册法规、技术指南和行业标准,具有较强的理解能力。
4、熟练使用办公软件,具备一定英文读写能力,能够熟练阅读、检索英文文献。
5、熟悉eCTD软件,有执业药师、药学类工程师、PMO等资格证书者优先。
以担保或任何理由索要财物,扣押证照,均涉嫌违法。

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • China

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 14, 2024
Company Overview
浙江华海药业股份有限公司
浙江华海药业股份有限公司

Current Openings: 0

Zhejiang Huahai Pharmaceutical Co.,Ltd. is a multinational enterprise, committed to providing high-quality medical and health products to patients around the world. The company is mainly engaged in the development, production and sales of APIs (Active Pharmaceutical ingredients), intermediates and multi-dose formulations that cover fields such as cardiovascular, psychiatric, anti-virus and anti-histamine. Currently, the company has owned more than 30 subsidiaries and has built long-term cooperative relationships with over 500 pharmaceutical companies around the world. As one of the leading enterprises, Huahai Pharmaceutical is the first pharmaceutical company in China that receives FDA approvals for generic drugs.
Are you an employee? 🌟
Explore Biotech Jobs

Find the one that suits your cosmic aspirations. Search open positions across the web, find opportunities uniquely matched to your skills, and read reviews on companies worldwide. 🚀💼🌎

Are you an employer? 🌟

Hire Top Talent in the Biotechnology Industry.

Post jobs, search for stellar candidates, and conduct the complete hiring process—all from your desktop or mobile phone. 🚀🔬👩‍🚀