, commercial, HMO) EClinicalWorks, EMA, or other EMR software Exciting Perks: 40% off products and procedures, as well as the...
Administration (FDA), European Medicines Agency (EMA), and Pharmaceuticals and Medical Devices Agency (PMDA) Ability to travel 50...
: Deep understanding of FDA (CFR)/EMA regulations (USP, Annex 1), FDA Guidance (Sterile Drug Products Produced by Aseptic... & Regulatory Compliance: Deep understanding of FDA (CFR)/EMA regulations (USP 790 and 1790, Annex 1), FDA Guidance (Container...
and audits (FDA, EMA, internal, or client audits) Strong technical writing skills with attention to detail and data integrity...
verbal and written communication skills. Excellent interpersonal and customer service skills. Working knowledge of EMA...
Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements...
Strong knowledge of regulatory standards (FDA, ISO, Anvisa, EMA) and quality systems Experience supporting audits and maintaining...
and commercial manufacturing Regulatory requirements for biologics (FDA, EMA, ICH) Modalities such as monoclonal antibodies...
. Prior FDA and EMA submissions experience. Technical expertise and knowledge of experimental design and analyses using... quantitative issues in simple terms. Solid understanding of Regulatory (FDA/EMA/ICH) guidance with the ability to interpret...
verbal and written communication skills. Excellent interpersonal and customer service skills. Working knowledge of EMA...