Karin Pihel
Senior Director, Regulatory Affairs @Sumitomo Pharma America, Inc.
Durham, NC, US
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MOBILE NUMBERS
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WORK HISTORY
Jul 2023 — Present
Senior Director, Regulatory Affairs @Sumitomo Pharma America, Inc.
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Regulatory lead for RETHYMIC, a commercial tissue-based regenerative medicine • Led Agency regulatory interactions to advance RETHYMIC initiatives, including addition of a new manufacturing facility • Wrote and edited sections of regulatory submissions
EDUCATION
1991 — 1996
The University of North Carolina at Chapel Hill
Ph.D., Chemistry
1987 — 1991
Rensselaer Polytechnic Institute
B.S., Chemical Engineering
SKILLS
CmcV&VCgmpQuality AssuranceVaccinesChemical EngineeringFdaBiotechnologyClinical DiagnosticsMedical DevicesDrug DevelopmentBiologicsBiological ProductsIch GuidelinesMedical DiagnosticsChemistryValidationPharmaceutical IndustryQuality SystemGmpQuality SystemsRegulatory Affairs
ABOUT KARIN PIHEL
Regulatory Affairs Certified (RAC) Proficient in the following: • Product…
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