Regulatory Affairs Assistant

Description

Position Summary: Pharmaceutical or biochemistry professional with experience in sanitary registrations to ensure continuity and expansion of the product portfolio, performing technical and administrative tasks. Key Highlights: 1. Key role in managing and expanding sanitary registrations of products. 2. Strategic collaboration with foreign suppliers and the commercial department. 3. Active participation in compliance with quality regulations. **REQUIREMENTS:** * Bachelor's degree or graduate in Pharmacy and Biochemistry. (mandatory) * Minimum 1 year of experience handling sanitary registrations for medical devices and/or pharmaceuticals. * Minimum 1 year of experience in pharmacies, pharmaceutical laboratories, and/or companies selling medical equipment. * Must reside in areas near Surco. * English language proficiency: intermediate level. **RESPONSIBILITIES:** * Preparation of dossiers for obtaining modifications, expansions, changes, initial registration, re-registration, and updates of Sanitary Registrations and Certifications to ensure uninterrupted product commercialization and expand the company's product portfolio. * Preparation of technical inquiries and coordination with the technical departments of foreign suppliers. * Responding to technical inquiries regarding products from the commercial department. * Preparing, maintaining, and managing dossiers. * Preparing and verifying the technical documentation required to obtain Sanitary Registration of products before DIGEMID. * Conducting quality inspections and verifying compliance with Good Practices within the company. * Supporting registration and re-registration of sanitary registrations. * Monitoring stock depletion. * Performing expansions or changes in product presentation formats. * Verifying GPP (Good Pharmacy Practices) compliance at assigned locations. * Tracking all dossier-related matters for various procedures according to national and international programs. * Other duties as assigned. **SPECIFIC KNOWLEDGE:** * Knowledge of Supreme Decree No. 016-2011. * Knowledge of Classes 1, 2, and 3. * Basic knowledge of GMP, GPP, GLP. * Knowledge of the VUCE system. **WORK SCHEDULE:** * Working hours: Monday to Friday: 7:30 AM to 4:40 PM; Saturday: 7:30 AM to 1:30 PM. **BENEFITS:** * Pleasant work environment. * Opportunity to join a solid company in the sector. * Formal payroll under the general regime. Employment type: Full-time Salary: S/.1,500.00 - S/.1,800.00 per month Application questions: * Are you available to start immediately? * Please indicate your English language proficiency level, both spoken and written: Basic, Intermediate, or Advanced. * Do you have experience in this position? How many years? Please detail. * What is your proficiency level with Excel and other Microsoft Office tools? * What are your salary expectations? Please provide your phone number for contact purposes and specify your district of residence. Work location: On-site employment