MSD, Colombia

Former Regulatory Affairs Director Northern Cluster

Pharmacist with experience of more than 20 years in Management and Direction of Regulatory Affairs Areas in Multinational Biopharmaceutical Companies at local and regional level LATAM, with broad record of successfully sanitary registrations of innovative medicinal products Chemical, Biologics, Biotechnology, Vaccines, Oncologic and for Hospital use, OTC. As MBA-strategic Management I have mindset to plan, manage, drive and control in the most successful way the activities of the Regulatory Affairs Area & Quality Assurance . I am a positive Leader that works in a collaborative way with other cross-functional key areas like Access, Policy, Medical, Marketing to get results as a Team. I have excellent negotiation skills, relationships of high impact and prestige and goodwill with Regulatory Agencies and MoH staff as well as with local Pharma Associations. Expert in sanitary regulations, Regulatory Intelligence and Regulatory Policy assuring the compliance with the sanitary laws in force. Experience as member of the Board of Directors. Recent experience as Consultant in Regulatory Affairs regarding sanitary regulations and the current environment to register specialities, orphan drugs and rare diseases medicinal products in Colombia. Experience as regional LATAM technical & regulatory affairs Director.