Christy Nardelli

Director, Regulatory Cmc Lead @Propharma Advertising, Promotional Review, & Labeling

Chicago, IL, US
MOBILE NUMBERS
+12•••••••27

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WORK HISTORY

Mar 2017 — Present

Director, Regulatory Cmc Lead @Propharma Advertising, Promotional Review, & Labeling

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Chicago, IL, US

EDUCATION

1973 — 1977

Youngstown State University

BS, Combined Sciences - Chemistry, Biology, Physics

SKILLS

PharmaceuticalsIndRegulatory AffairsLifesciencesBiopharmaceuticalsEuropean UnionOnline CommunicationsBiochemistryLife SciencesGlpEuBiologicsBiotechnologyResearch and Development (R&D)EctdGmpPharmaceuticsGood Laboratory Practice (Glp)StrategyAndaRegulatory StrategyRegulatory SubmissionsR&DPharmaceutical IndustryFdaU.s. Food and Drug Administration (Fda)

ABOUT CHRISTY NARDELLI

Over 30 years of chemistry, manufacturing, and controls (CMC) focused technical and global regulatory expertise in the areas of healthcare regulatory strategy, policy, product development, compliance, new product submissions and launches, life-cycle management/expansion, agency meeting preparation, due diligence, regulatory operations, crisis management, mergers/acquisitions/ spin-offs, quality assurance/compliance remediation, general GMP and pre-approval inspection support, outsourcing strategies and intelligence/policy for Biologics, Drugs, and Nutritionals.

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