摘要
-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 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 :
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Business Unit
Universal Hierarchy Node
Company / Legal Entity
CN14 (FCRS = CN014) China Novartis Institutes for BioMedical Research Co., Ltd.
Functional Area
Research & Development
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