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 integral 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:
Minimum of 2 years of experience in Regulatory Affairs within Latin American countries.
Experience with regulatory submissions and lifecycle management activities for pharmaceutical products.
Knowledge of applicable pharmaceutical regulations in at least one Latin American country.
Experience using regulatory and quality databases.
Proactive, detail-oriented, and capable of managing multiple projects simultaneously.
Strong ability to work independently, as the direct manager will be based remotely.
Skills Desired
Analytical Skill, Clinical Trials, Collaboration, Detail-Oriented, Lifesciences, Project Planning, Regulatory Compliance