I am a Pharmaceutical Chemist with postgraduate studies in Epidemiology and an MBA, experienced in leading end-to-end production operations and projects within the pharmaceutical and healthcare sectors. I have extensive expertise in regulatory affairs for Colombia and LATAM countries, including submissions, legal formalities, sanitary notifications (CAN), licenses, import permits, and serving as an Authorized Person (Technical Director in Colombia). Additionally, I am well-versed in quality management systems (GxP, GMP, GACP, GCP, ISO 9001, ISO 17025), with significant experience in inspections/audits, documentation management, handling complaints and investigations, KPIs, validations, and obtaining quality regulatory certifications (e.g., INVIMA, COFEPRIS, ANVISA, DIGEMID, SIC) for pharmaceutical and healthcare products. I have participated in technical reviews of national and international health regulations with the Colombian government, including contributions to the PARF Network within PAHO-WHO (for Harmonization of Regulatory Requirements) and regulations concerning biological medicines, medicinal gases, dietary supplements, and GMP inspections. Furthermore, I have experience in first, second, and third-party GxP audits, both as an audit team leader and as an auditor for specific processes such as quality, production, logistics, and regulatory affairs. My auditing experience encompasses over 120 pharmaceutical plants, including national and international audits in countries such as Colombia, Brazil, Mexico, Ecuador, Venezuela, India, Ukraine, Russia, South Korea, and China. I am a responsible professional with strong skills in negotiation, leadership, teamwork, goal orientation, communication, analytical and strategic thinking, interpersonal relations, problem-solving, multitasking, and business development. I am also highly motivated to learn new subjects and engage in activities that enhance both my professional and personal growth.
