regulations (including to the FDA, EMA, MHRA, and all assigned international RAs), processes, PV agreements, and database... in agency inspections including FDA, EMA, Health Canada and others Management of change management, compliance deviations...
, SI, (Source Inspector), Electrical Journeyman License, NACE CIP 1, 2, 3, EMA (Expediting Management Association) Basic, Advanced...
. Other duties as assigned Required Skills / Abilities Strong knowledge of applicable US FDA, ICH, EMA, MHRA regulations...
administration, and ecological momentary assessment (EMA), while ensuring participant safety, protocol fidelity, and a positive...
adherence to cGMP/cGDP/cGLP, ICH, and relevant regional regulations (e.g., FDA, EMA, MHRA, PMDA). Maintain robust Quality...
, PDA, ASQ, RAPS). Remain at the forefront of US, EMA, and ROW regulatory changes and current expectations Team... of global regulatory frameworks (FDA, EMA, MHRA, ICH, WHO). Proven ability to support sales and business development...
interactions on CMC topics). Current knowledge of FDA, EMA and ICH regulations/guidance and requirements, with a demonstrated..., and understanding of FDA/EMA requirements for corresponding dossier development Competencies Collaborative – Openness, One Team...
, SI, (Source Inspector), Electrical Journeyman License, NACE CIP 1, 2, 3, EMA (Expediting Management Association) Basic, Advanced...
, Environmental Health & Safety, Human Resources, EMA regulations and other Quality System regulations, as applicable Ensures...
. Familiarity with SAP or other ERP systems preferred. Strong working knowledge of cGMP, GDP, and FDA/EMA regulatory expectations...