**REGULATORY AFFAIRS MANAGER (QFB) / MEDICATION DISTRIBUTION** **Requirements:** Education: Pharmaceutical Chemist Biologist with License Experience: Minimum of 5 years in the position, extensive knowledge ensuring compliance of the quality management system according to Mexican Official Standards for handling, storage, and distribution of health medications. Handling of biologicals, documentation systems, and medication distribution. Maintenance of the Quality Management System, deviations, change controls, procedures before COFEPRIS. Essential knowledge of NOM-059-SSA, NOM-241-SSA, NOM-240-SSA, NOM-137-SSA, NOM-220-SSA, NOM-072-SSA, ISO 9001:2015. **Responsibilities:** \-Establish the strategic direction for continuous improvement of the quality management system. \-Keep sanitary registrations updated and valid, as well as implement and execute processes for new product registrations within the company. \-Responsible for administering and supervising the quality management system. \-Management of sanitary licenses. \-Investigate and monitor laws and regulations, and disseminate information to others within the organization. \-Review the organization to identify regulatory issues and act as a liaison with government regulatory agencies. \-Ensure compliance with NOM-059-SSA, NOM-241-SSA, NOM-240-SSA, NOM-137-SSA, NOM-220-SSA, NOM-072-SSA, ISO 9001:2015 regulations. \-Handling of biologicals. \-Knowledge of validation. \-Supplier development. \-Develop processes to notify the organization when regulatory changes arise and serve as a reference point for different departments. \-Representative for procedures before COFEPRIS, government agencies, and associations. \-Compliance with internal and external audits. \-Verify the documentary system for change controls, including risk management for assessing and evaluating the impact of proposed changes on processes, suppliers, computerized systems, areas, services, equipment, regulatory requirements, product quality, and materials. \-Analyze quarterly sources of information from the management system, such as process performance, work operations that could affect product and service quality, audit results, quality records, service reports, potential future customer needs, and complaints. **We Offer:** Gross salary $45,000 Statutory benefits Working hours: Monday to Friday from 9 AM to 7 PM Location: Reforma, one block from Insurgentes, Cuauhtémoc Position type: Full-time, Indefinite term Salary: $45,000.00 per month Application Question(s): * How many years of experience do you have in Medication Distribution? Work Location: On-site position