Regulatory Affairs Assistant

Description

Job Summary: Pharmacy and Biochemistry professional responsible for the preparation and management of sanitary registrations, technical coordination with suppliers, and support to the commercial department, ensuring continuity and expansion of the product portfolio. Key Highlights: 1. Key role in the preparation and management of sanitary registrations 2. Technical coordination with foreign suppliers 3. Technical support to the commercial department and quality verification **REQUIREMENTS:** * Bachelor's degree or graduate in Pharmacy and Biochemistry. (Mandatory) * Minimum 1 year of experience in sanitary registration of medical devices and/or pharmaceuticals. * Minimum 1 year of experience in pharmacies, pharmaceutical laboratories, and/or companies selling medical equipment. * Must reside in areas adjacent to Surco * English language proficiency: **intermediate level** **RESPONSIBILITIES:** * Preparation of files for modifications, extensions, changes, registration, re\-registration, and updating of Sanitary Registrations, and Certifications to ensure uninterrupted product commercialization and increase the company's product portfolio. * Drafting of technical inquiries and coordination with the technical departments of foreign suppliers. * Responding to technical inquiries regarding products from the commercial department. * Conducting, maintaining, and managing dossiers. * Preparing and verifying the technical documentation required to obtain Sanitary Registration of products from 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 extensions or changes in product presentation format. * Verifying GPP (Good Pharmacy Practices) compliance at assigned locations. * Tracking all matters related to product dossiers for various procedures according to national and international programs. * Other duties as assigned. **SPECIFIC KNOWLEDGE:** * Knowledge of Supreme Decree 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 specify 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 indicate your district of residence. Work location: On-site employment