Heloisa Fostinone

Heloisa Fostinone is a highly experienced regulatory professional specializing in clinical trials within the Latin American market. Currently serving as Senior Regulatory Manager for Clinical Trials at Amgen since October 2012, Heloisa oversees regulatory management across Argentina, Brazil, Chile, Colombia, Peru, and Panama, ensuring compliance with local regulations and best practices. Responsibilities include defining regulatory submission strategies, providing regulatory support for various company functions, and managing budgets for clinical projects. Previous roles include Regulatory Manager for Clinical Trials at Amgen, Clinical Operations Manager, and CTA Regulatory & Start-up Associate at Sanofi, with earlier experience as Regulatory Specialist for Clinical Studies at Janssen-Cilag. Heloisa holds a Specialist degree in Business and Administration from FGV - Fundação Getulio Vargas and a Bachelor's degree in Pharmacy from USP - Universidade de São Paulo, bringing extensive knowledge in therapeutic areas such as cardiovascular, oncology, and infectious diseases.