-Contributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.

Major accountabilities:

•Achieve the best product registration with commercially attractive labelling in accordance with registration plan -Maintain and secure product license in terms of CMC/CDS/safety update according to local regulations/law/guidelines, company strategy and global compliance -Ensure compliance with NP4, KRPIA code of conduct, relevant regulations and laws for related CPO activities (DRAGON update, RMP, packing materials, promotional materials/activities, PMS/drug safety reporting etc.) -Foster and maintain good relations with internal and external stakeholders -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

•Project & stakeholder feedback -Product license update in terms of CMC in agreed timeline -Adherence to Novartis policy and guidelines

Minimum Requirements:

Work Experience:

•Functional Breadth.

•Cross Cultural Experience.

•Operations Management and Execution.

•Project Management.

Skills:

•Analytical Skill.

•Clinical Trials.

•Collaboration.

•Detail Oriented.

•Lifesciences.

•Project Planning.

•Regulatory Compliance.

Languages :

•English.

为什么选择诺华：帮助患者及家属不仅需要创新科学，还需要一支包括你我他在内的充满智慧与激情的团队，大家相互协作、支持与激励。共同实现突破，改变患者的生活。一起共创更好的未来，你准备好了吗？

加入我们的诺华网络：这不是您心仪的职位？欢迎加入诺华人才社区，与我们保持联系，及时了解合适的职业机会。您也可以关注诺华集团招聘微信公众号及诺华集团招聘微信视频号。

薪酬与福利：您可以前往诺华官网了解我们帮助您实现个人与职业发展的举措。

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?

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. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.

Benefits and Rewards: Go to Novartis career website to learn about all the ways we’ll help you thrive personally and professionally.

Collaboration

Regulatory Compliance

Analytical Skill

Project Planning

Detail-Oriented

Lifesciences

Clinical Trials