Job description
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 Biz.
Chat Languages : English. Skills Desired Analytical Skill, Clinical Trials, Collaboration, Detail-Oriented, Lifesciences, Project Planning, Regulatory Compliance