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...
with ICH-GCP, FDA/EMA regulations, and internal SOPs. Proactively identify risks and develop/implement mitigation strategies...
background) Experience using ModMed EMA preferred but not required Excellent interpersonal and communication skills...
and audits (FDA, EMA, internal, or client audits) Strong technical writing skills with attention to detail and data integrity...
administration, and ecological momentary assessment (EMA), while ensuring participant safety, protocol fidelity, and a positive...
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...
, SI, (Source Inspector), Electrical Journeyman License, NACE CIP 1, 2, 3, EMA (Expediting Management Association) Basic, Advanced...
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...