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Summary:
- 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.
About the Role:
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 according General timelines
- RA Support in MAP/PSDS
- RA Policy handling
- Training curricula review and GOPs applicability
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.