Amy Waterhouse
Vice President, Regulatory and Government Affairs
Ms. Waterhouse joined BioMarin in January 2000 and currently serves as Vice President, Regulatory and Government Affairs. Her responsibilities include oversight of the worldwide regulatory and governmental strategies for all BioMarin products, including Aldurazyme® (laronidase) for MPS I, Naglazyme® (galsulfase) for MPS VI, and
KUVAN® (sapropterin dihydrochloride)Tablets,
all of which were granted marketing authorization under her leadership. Prior to coming to BioMarin, Ms. Waterhouse was head of Regulatory Affairs at Onyx Pharmaceuticals where she managed worldwide regulatory activities for viral therapies in development for the treatment of oncology indications and served as primary contact with all regulatory agencies regarding preclinical, clinical and CMC aspects of product development. From 1991 to 1995, she served in a variety of roles at Celtrix Pharmaceuticals pertaining to quality assurance, clinical research and regulatory affairs. Ms. Waterhouse holds a B.S. in biology from San Francisco State University and has completed numerous professional development courses. She is a member of the Drug Information Association and the Regulatory Affairs Professionals Society.