Regulatory Affairs Specialist

REQ-10023226
Sep 20, 2024
Serbia

Resumen

贡献和支持提交产品注册,进度报告,补充,修订和/或定期经验报告的发展。支持该部门的所有注册活动,以确保符合当地药品监管环境的要求。

About the Role

Major Accountabilities

~ 根据注册计划,通过具有商业吸引力的标签实现最佳产品注册
~ 根据当地法规/法律/准则、公司战略和全球合规性,维护并保护 CMC/CDS/安全更新方面的产品许可证
~ 确保遵守 NP4、KRPIA 行为准则、相关 CPO 活动的相关法规和法律(龙更新、RMP、包装材料、促销材料/活动、PMS/药物安全报告等)
~ 促进和保持与内部和外部利益相关者之间的良好关系
~ 在收到诺华产品后24小时内报告与诺华产品相关的技术投诉/不良事件/特殊情况
~ 营销样本的分发(如适用)

Key Performance Indicators

贡献和支持提交产品注册,进度报告,补充,修订和/或定期经验报告的发展。支持该部门的所有注册活动,以确保符合当地药品监管环境的要求。

Work Experience

~运营管理和执行
~项目管理
~职能广度
~跨文化经历

Skills

~分析能力
~项目规划
~临床试验
~协作
~生命科学
~注重细节
~法规遵从性

Language

英语

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Development
Innovative Medicines
Serbia
Serbia
Research & Development
Full time
正式
No
A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
REQ-10023226

Regulatory Affairs Specialist

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  1. https://www.novartis.com/about/strategy/people-and-culture
  2. https://talentnetwork.novartis.com/network
  3. https://www.novartis.com/careers/benefits-rewards
  4. https://novartis.wd3.myworkdayjobs.com/zh-CN/Novartis_Careers/job/Serbia/Regulatory-Affairs-Specialist_REQ-10023226
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