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management team
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Amy Waterhouse |
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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 and Naglazyme&#reg; (galsulfase)
for MPS VI, both 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. |
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