REGULATORY AFFAIRS ASSISTANT

Description

Position Summary: We are seeking a university graduate in Pharmacy and Biochemistry to prepare and manage regulatory dossiers, ensuring continuity and expansion of the product portfolio. Key Responsibilities: 1. Regulatory affairs management for medical devices. 2. Preparation of dossiers for sanitary registrations. 3. Conducting quality inspections and GMP audits. **REQUIREMENTS**: * University graduates only in PHARMACY AND BIOCHEMISTRY. * Recent graduates or university students currently enrolled in their final academic cycles. * Experience in regulatory affairs for medical devices. * Proficiency in Word and Excel (intermediate level). * Solid knowledge of GMP (mandatory). * Intermediate English proficiency. * Must reside in areas adjacent to Surco. **RESPONSIBILITIES:** * Preparing dossiers for modifications, extensions, changes, registration, re-registration, and updates of Sanitary Registrations and Certifications to ensure uninterrupted commercialization of products and expand the company’s product portfolio. * Drafting technical inquiries and coordinating with the technical departments of foreign suppliers. * Responding to technical inquiries from the commercial department regarding products. * Preparing, maintaining, and managing dossiers. * Preparing and verifying the technical documentation required to obtain Sanitary Registration of products from DIGEMID. * Conducting quality inspections and GMP compliance audits within the company. * Supporting Sanitary Registration and Re-registration processes. * Monitoring stock depletion. * Managing extensions or changes in product presentation formats. * Verifying GMP compliance at assigned locations. * Tracking all matters related to product dossiers for various procedures according to national and international programs. * Other duties as assigned. **WORK SCHEDULE:** * Monday to Friday: 7:30 am \- 16:40 pm * Saturdays: 7:30 am \- 13:30 pm **BENEFITS:** * Formal employment contract \+ statutory benefits. * Job-related training. * Work certificate. Employment Type: Full-time Salary: S/.1,500\.00 \- S/.1,800\.00 per month Application Question(s): * Are you available to start immediately? * Please indicate your salary expectations, district of residence, and current WhatsApp number. * Please detail your experience. Work Location: On-site employment