Summary
About the Role
Major Accountabilities:
- Support product license registration / License maintenance for existing products, i.e. CMC variations, IPL updates, license renewals, etc.
- Follow local HA regulations to update product-related changes in a timely manner
- PMF registration and GMP follow-up renewals
- PSUR & RMP submission
- Regulatory and documentation support for other function/ TAs e.g. Market Access, KAM, Marketing, promotion materials review
- Abide by internal SOPs and update RA systems in a timely manner
- Other assignments
Key performance indicators:
- Product license update in terms of CMC/leaflet update in agreed timeline
- Adherence to Novartis policy and guidelines
- Project & stakeholder feedback
Minimum Requirements:
Work Experience:
- at least 1-2 year experience in Drug regulatory affairs
Education:
- Bachelor's degree or above, major in pharmacy or medical science-related fields
Languages :
- Excellent command of written and spoken English and Mandarin Chinese.
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
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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
