Fernanda Bortolotti Batista

Fernanda Bortolotti Batista is Regulatory Affairs Manager at NC Farma, one of the leading pharmaceutical companies in Brazil. With over a decade of experience in regulatory affairs, she is responsible for the strategic management of post-approval changes, regulatory compliance, and lifecycle maintenance of pharmaceutical products. Her professional journey includes the implementation of regulatory frameworks aligned with international guidelines, such as the Post-Approval Change Management Protocol (PGMP). Fernanda plays an active role in regulatory dialogue with ANVISA and industry associations, contributing to initiatives aimed at regulatory convergence and continuity of supply in Latin America. She holds a degree in Industrial Pharmacy and an MBA in People Management. Her work is guided by a strong commitment to public health, regulatory excellence, and collaboration across the pharmaceutical value chain.