Senior Director Regulatory Affairs
Pam Monterola has served as our Senior Director of Regulatory Affairs since our inception in April 2021. Dr. Monterola is an experienced RA professional with a combined 14 years of diverse industry experience in global Regulatory CMC and analytical development. She led, developed, and implemented regulatory strategies and risk assessments for product development teams from pre-IND to post approvals of small molecules, biologics, and oligonucleotide-based products.
She has worked directly on approved drug products in the market, such as Telaprevir, Kevzara, and Dupixent. Prior to joining Aceragen Inc., Dr. Monterola serves in positions of increasing CMC related responsibility in several small and large pharmaceutical companies, such as Vertex, Hospira, Regeneron, Turning Point, and miRagen (Viridian Therapeutics). Pam holds a Ph.D. in Chemistry (Analytical Chemistry) from University of Florida and a B.S. in Chemistry from University of the Philippines.