Monique Fleck
Associate Director, Global Regulatory Affairs at Amicus Therapeutics
Based in Mt. Laurel, United States
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Seniority
Director
Department
Science
Location
Mt. Laurel
Industry
Biotechnology Research
Company size
575
Contact information
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m•••••••@biomarin.com
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Background
About Monique Fleck
Regulatory affairs professional specializing in the execution of regulatory strategy for pre-approval and post-approval drugs and biologics in the therapeutics areas of neurology, GI, hematology, ophthalmology and internal medicine, with a unique background in developing and marketing orphan drugs to treat rare diseases Experience as a US regulatory lead and primary Food and Drug Administration (FDA) contact responsible for seven products and the management of nine IND, two NDA, and five ODD, applications Experience is supplemented with MS in Regulatory Science courses including; medical device regulation, marketing in a regulated environment, cGMP compliance, IP patents and licensing, and practicum in regulatory science
Decision-makers
Other people at Amicus Therapeutics
- LCManager
Lisa Carl
Sr Manager, Medical Writing Document Quality · Science
- JSDirector
John Spaltro
Director, Global Regulatory Affairs, Early Development · Science
- DSManager
Debora Segalina
Commercial Project Manager · General Business & Management
- NLDirector
Nila Lad
Director · Research & Development
- HMDirector
Heather Mason Blair
Director, Managed Markets & Trade · Sales & Business Development
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