Alex Borrelli
Regulatory and Quality Manager at Kytopen
Based in Bedford, United States
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Seniority
Manager
Department
Legal
Location
Bedford
Industry
Biotechnology Research
Company size
29
Contact information
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a•••••••@kytopen.com
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Background
About Alex Borrelli
Regulatory affairs professional with 19 years of experience in the pharmaceutical industry with 12 of those in RA. Extensive experience working with drug/device combination products regulated under CDER with a small molecule API which were either cross labeled or single entity. Lifecycle management has included taking products from development through commercial launch. After completing my Masters degree I spent several years performing basic research in academia and industry. In 2008 I expanded my skill set to include some quality control responsibilities. My work in quality also drew me into the regulatory aspect of pharma as much of the data I generated went towards regulatory filings. In 2011 I transitioned to a full time regulatory role, starting as a generalist and gradually focusing more on chemistry, manufacturing, and controls (CMC). The therapeutic areas I have been involved in to date include ophthalmic and ear/nose/throat.
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