- 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 Fuse, BeSure, code of conduct, relevant regulations and laws for related CPO activities (DRAGON update, RMP, packing materials, promotional materials/activities, 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
Registered with the SAPC. Min BPharm Degree
Work Experience
- Regulatory experience min 3-5 years. Able to create and submit eCTDs.
- Functional Breadth.
- Cross Cultural Experience.
- Operations Management and Execution.
- Project Management.
- Analytical Skill.
- Collaboration.
- Detail Oriented.
- Lifesciences.
- Project Planning.
- Regulatory Compliance.
- English.
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