Raymond Cerny

Sr Scientist, Chemistry, Mfg & Cntrl @Cardinal Health

Overland Park, KS, US

Apply pharmaceutical industry experience and regulatory affairs knowledge to meet project objectives, while managing several ongoing and shifting priorities across multiple project timelines and scopes of work.Author CMC related variations for drug products registered across multiple markets, by identifying the drug products current registration status in the affected markets, gather the currently registered CMC information for comparison against proposed submission section content, determine specific market documentation requirements, and prepare appropriate documentation for review and approval by product management.Conduct thorough review and evaluation of CMC documents and other data (QA, QC and manufacturing) to ensure compliance with USP, FDA and ICH quality guidelines.Prepare, assemble and review FDA Annual Reports, DMF updates and perform life cycle management.Cardinal Health Regulatory Sciences provides global product development consulting services to help biopharmaceutical and medical device companies accelerate regulatory approval while delivering high quality documentation and guidance. Our collaborative, cross-functional approach has resulted in more than 500 product approvals worldwide and we are currently working to drive development efficiencies in more than 140 countries. Our team of more than 200 regulatory and scientific experts, averaging 18 years of industry experience, helps our clients accelerate time to market and reduce risk throughout the entire development continuum.

Roosevelt University

MBA, International Business

College of Lake County

Pre-Engineering

Iowa State University

BS, Chemical Engineering