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Regulatory Affairs CMC Professional with expertise in filing ANDAs for sterile parenterals in eCTD format which includes electronic rendering of files and publishing to FDA. Successful in resolving deficiencies from Regulatory Agency, submitting significant post approval supplements and maintaining the facility’s Type V Drug Master File for sterile manufacture. Detail oriented with strong written, verbal and interpersonal skills.
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ManagerFresenius Kabi Usa Jan 2021 - PresentLake Zurich, Illinois, Us -
Regulatory Technical ManagerFresenius Kabi Usa Apr 2020 - Dec 2021Lake Zurich, Illinois, Us
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Senior Manager Regulatory AffairsAreva Pharmaceuticals Apr 2017 - Apr 2020Georgetown, In, Us -
Senior Regulatory Affairs AssociateWest-Ward Pharmaceuticals Sep 2014 - Mar 2017File post approval supplements and amendments to approved and unapproved ANDAs to transfer the site of drug product manufacture. This includes an evaluation of the facility of transfer and review of procedures, specifications, protocols, test methods, master production records, equipment validation and media fill data to determine regulatory impact.• Independently author supplements and amendments for facility transfer.• Author responses to FDA Information Requests and Complete Response Letters.• Author annual reports for approved ANDAs for submission to FDA within the required timeframe.
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Regulatory Affairs Cmc AssociateBoehringer Ingelheim Aug 2008 - Sep 2014Ingelheim Am Rhein, Rhineland-Palatinate, DeFiled new ANDAs (505 (j)) in eCTD format according to FDA guidelines with introductory experience with NDAs (505(b)(2)). Managed the lifecycle of 29 approved ANDAs and 10 unapproved ANDAs which included a review of any changes made to specifications, stability protocols, test methods and master production records for content and appropriateness for use and determined Regulatory impact. Managed the facility’s Drug Master File which included review of any change to procedures, facility descriptions, equipment validations and validation philosophy. -
MicrobiologistBoehringer Ingelheim Jun 2006 - Aug 2008Ingelheim Am Rhein, Rhineland-Palatinate, DePerformed bioburden and endotoxin analysis on raw materials. Analyzed in-process and final product samples for bioburden, endotoxin, particulate matter and sterility. Performed method development for routine testing of final product and in-process samples. Identified microorganisms from environmental, process water and product samples.
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Environmental Monitoring TechnicianBoehringer Ingelheim Nov 2004 - Jun 2006Ingelheim Am Rhein, Rhineland-Palatinate, DeResponsible for environmental monitoring of production areas including surface contact, viable air, and nonviable air monitoring. Responsible for personnel monitoring during active filling operation. Performed aseptic technique and proper aseptic behavior for a sterile room environment.
Dawn Casey Skills
Dawn Casey Education Details
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Cleveland State UniversityBachelor Of Science In Biology
Frequently Asked Questions about Dawn Casey
What company does Dawn Casey work for?
Dawn Casey works for Fresenius Kabi Usa
What is Dawn Casey's role at the current company?
Dawn Casey's current role is Manager at Fresenius Kabi USA.
What is Dawn Casey's email address?
Dawn Casey's email address is dc****@****rma.com
What is Dawn Casey's direct phone number?
Dawn Casey's direct phone number is +173254*****
What schools did Dawn Casey attend?
Dawn Casey attended Cleveland State University.
What skills is Dawn Casey known for?
Dawn Casey has skills like Regulatory Affairs, Pharmaceutical Industry, Gmp, Sop, Cmc.
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