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.
Job Description 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 and lifecycle maintenance of pharmaceutical products.
- Adaptable mindset, adaptable to change, and proactive approach to work.