Regulatory Affairs Specialist

**Job Description 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. **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. * Flexible mindset, adaptable to change, and proactive approach to work. * Provide your feedback on BizChat --------------------------------    **Languages** : * English. **Skills Desired** Analytical Skill, Clinical Trials, Collaboration, Detail-Oriented, Lifesciences, Project Planning, Regulatory Compliance