Kathryn Yaramishyn
Principal Consultant @Opus Regulatory Inc.
Philadelphia, PA, US
EMAILS
MOBILE NUMBERS
+91 *********19
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WORK HISTORY
Dec 2021 — Present
Principal Consultant @Opus Regulatory Inc.
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Philadelphia, PA, US
EDUCATION
N/A
Commonwealth University-Bloomsburg
BS, Biology
SKILLS
OncologyClinical ResearchEctdStandard Operating Procedure (Sop)BiotechnologyPharmaceutical IndustrySopFdaClinical DevelopmentClinical TrialsGxpCRO ManagementPharmaceuticsDrug DevelopmentGcpBiopharmaceuticalsLife SciencesPharmacovigilanceTherapeutic AreasChange ControlDocumentumStrategyLabelingCross-Functional Team LeadershipMedical AffairsRegulatory Affairs21 Cfr Part 11PharmaceuticalsRegulatory RequirementsIndRegulatory SubmissionsU.s. Food and Drug Administration (Fda)Good Clinical Practice (Gcp)Vaccines
ABOUT KATHRYN YARAMISHYN
Regulatory Affairs specialist with strong experience in the pharmaceutical industry. Expertise includes advertising & promotional review, regulatory project management, strategy, product development and labeling negotiations with the FDA. Preparation and coordination of documents for global regulatory teams. European regulatory operations experience (expatriate assignment in Germany).
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