REGULATORY AFFAIRS ASSISTANT

Description

Position Summary: Pharmacy and Biochemistry professional responsible for preparing and managing sanitary registration dossiers and providing technical support for medical devices, ensuring continuity and expansion of the product portfolio. Key Responsibilities: 1. Sanitary registration management and product certification 2. Technical support and coordination with foreign suppliers 3. Verification of Good Storage Practices (GSP) **REQUIREMENTS**: * University graduates or students in PHARMACY AND BIOCHEMISTRY only. * 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 GSP (mandatory). * Intermediate English proficiency. * Must reside in areas adjacent to Surco. **RESPONSIBILITIES:** * Preparation of dossiers for modifications, extensions, changes, initial registration, re-registration, and updates of Sanitary Registrations and Certifications to ensure uninterrupted product commercialization and expand the company's product portfolio. * Drafting technical inquiries and coordinating 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 for products from DIGEMID. * Conducting quality inspections and verifying compliance with good practices within the company. * Supporting Sanitary Registration and Re-registration processes. * Monitoring stock depletion. * Implementing extensions or changes to product presentation formats. * Verifying GSP compliance at assigned locations. * Tracking all dossier-related matters for various procedures in accordance with national and international programs. * Other duties as assigned. **WORK SCHEDULE:** * Monday to Friday: 7:30 am \- 4:40 pm * Saturdays: 7:30 am \- 1:30 pm **BENEFITS:** * Formal employment registration \+ statutory benefits. * Job-related training. * Employment certificate. 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 salary expectations, district of residence, and current WhatsApp number. * Please detail your experience. Work Location: On-site employment