REGULATORY AFFAIRS ANALYST

Description

Position Summary: Abbott is seeking a Regulatory Affairs Analyst to implement strategies and plans that expand the portfolio through the acquisition of sanitary registrations. Key Highlights: 1. Implementation of innovative regulatory strategies 2. Responsible for obtaining sanitary registrations 3. Coordinates with various departments to ensure regulatory compliance **About Abbott** Abbott is a global healthcare leader that creates innovative science to improve people's health. We are always looking ahead, anticipating changes in medical science and technology. **Working at Abbott** At Abbott, you can do work that matters, grow and learn, take care of yourself and your family, be authentically you, and live a fulfilling life. You will have access to: **The Opportunity** This position is located at the Lince headquarters within the EPD (Established Pharmaceutical Products) division. Our broad portfolio of high-quality, differentiated-brand generic medicines spans multiple therapeutic areas, including gastroenterology, women's health, cardiometabolic, pain management / central nervous system, and respiratory pathways. As a Regulatory Affairs Analyst, you will be responsible for implementing innovative regulatory strategies and execution plans to expand the portfolio through the acquisition of sanitary registrations. **ORGANIZATIONAL RELATIONSHIPS:** Reports to: Regulatory Affairs Coordinator Coordinates with: All Department Heads, Coordinators, and Analysts from Operations, R\&D, Quality, Quality Assurance, Medical, Logistics Design, and other related positions. **What You’ll Do:** * Review and verify the technical documentation required for product sanitary registration. * Prepare and/or review registration or re-registration dossiers, formula changes, name changes, manufacturer changes, package inserts and/or labeling, and shelf-life extensions; additionally perform registration transfers and prescription scope expansions. * Collect and conduct bibliographic evaluations supporting the use of products not included in official reference publications. * Perform dossier analysis for renewal products within the established schedule. Any identified changes must be submitted within the defined timeline. * Achieve 100% CAPA closure by the committed deadline. * Meet submission and approval dates specified in the Change Control. * Execute LATAM regulatory remediation plans by providing required information from dossier-supplying plants and submitting CAPA-driven updates per product according to defined timelines. **Required Qualifications:** * Academic Background: Pharmaceutical Chemist * **Minimum 2 years of experience in similar roles within the pharmaceutical industry,** quality control, and regulatory affairs. * Knowledge of GMP. * Availability to work in Lince from 8:30 AM to 6:00 PM. **Abbott is an equal opportunity employer and conducts recruitment, selection, and hiring solely based on job-related qualifications, without regard to race, color, religion, creed, age, sex, nationality, gender identity or expression, sexual orientation, disability, marital status, veteran or military status, genetics, citizenship status, or any other condition protected by law.**