- 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 general 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 Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable)
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 Sandoz 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 Sandoz policy and guidelines
Minimum Requirements
Work Experience
- Minimum of 3 years of Regulatory Affairs experience within pharmaceutical companies in Chile.
- Strong knowledge of regulatory processes and requirements with the Institute of Public Health (ISP).
- Experience preparing regulatory submissions for new product registrations an