Kim Knutson Raymer

Executive Director, Regulatory Cmc @Arvinas

Iowa City, IA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Apr 2023 — Present

Executive Director, Regulatory Cmc @Arvinas

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New Haven, CT, US

EDUCATION

1987 — 1991

St. Olaf College

BA, Chemistry

SKILLS

Technical WritingClinical TrialsDrug DevelopmentExcelRegulatory SubmissionsStandard Operating Procedure (Sop)GmpBiotechnologyEctdRegulatory AffairsMicrosoft OfficeLife SciencesClinical DevelopmentPharmaceutical IndustryFdaU.s. Food and Drug Administration (Fda)ValidationPharmaceuticalsIndLivelinkDocument ManagementAttention to Detail

ABOUT KIM KNUTSON RAYMER

Kim has significant professional experience in regulatory affairs with a focus in regulatory Chemistry, Manufacturing, and Controls (CMC). She has more than 3 decades of extensive expertise in regulatory CMC for investigational and marketed drug products for both small molecules and biologic, leading the CMC development of clinical trial applications, global marketing authorizations, and post approval life cycle management. Kim has experience developing complex regulatory CMC strategies and negotiating with health authorities, and has often served as the lead author of regulatory CMC submissions. In addition to regulatory CMC expertise, Kim also contributes to overall regulatory strategy for early development programs, health authority agency interactions, regulatory intelligence, and regulatory project management.

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Kim Knutson Raymer — Executive Director, Regulatory Cmc at Arvinas in Iowa City, IA, US | Unifers