Summary
About the Role
- To set registration plan, to perform product registration in accordance with registration and launch plan, & maintain product license with local regulation and global compliance strategy -Review new projects and set development plan (timeline etc.) in collaboration with Global DRA and related CPO functions (Marketing, HE&P and CD&MA etc.) -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 -Perform IND application & get aproval to ensurestudy timeline in collaboration with medical team and Global DRA -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)
- Project & stakeholder feedback -Product license update in terms of CMC in agreed timeline -Adherence to Novartis policy and guidelines
Work Experience:
- Cross Cultural Experience.
- Operations Management and Execution.
- Project Management.
- Functional Breadth.
- NA.
- English.
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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