Heather Faulds

Heather Faulds joined Fulcrum in July 2024 from Alkermes, where she served as SVP, Regulatory Affairs. Heather brings over 20 years of experience leading global regulatory strategies across all phases of development, as well as multiple therapeutic areas and modalities. At Alkermes, Heather led the team that achieved FDA approval for LYBALVI® (olanzapine and samidorphan) for the treatment of schizophrenia and bipolar disease. Previously, Heather served as SVP, Regulatory Affairs at Scholar Rock where she led multiple functions spanning regulatory affairs, GxP compliance, pharmacovigilance, and medical writing, and was responsible for regulatory strategies across clinical programs for rare diseases and immuno-oncology. Prior to joining Scholar Rock, Heather spent 12 years at Biogen in roles of increasing responsibility across CMC regulatory and global regulatory strategy. While there, her leadership paved the way for several novel health authority approvals including SPINRAZA® (nusinersen), the first treatment for spinal muscular atrophy, which was approved by FDA in 90 days from submission. Heather also led regulatory activities for programs in Alzheimer’s Disease and Multiple Sclerosis. Heather holds a B.S. in Biology from the University at Albany and holds a Master’s of Regulatory Affairs and Health Policy from the Massachusetts College of Pharmacy.