by organizing and maintaining submission-ready documents in accordance with US FDA and global regulatory requirements (EMA, NMPA... across major health authorities (e.g., FDA, EMA, NMPA, PMDA, ANVISA, TGA, Health Canada) is preferred. Understanding...
requirements (FDA, EMA, ISO 14155, GCP, GDPR). Excellent organizational, leadership, and communication skills. Preferred...
compliance with 21 CFR Part 11, Annex 11, GAMP 5, FDA, EMA, and other global regulatory requirements. Review User Requirements...
Authority regulations (FDA, EMA, HealthCanada, etc.) Experience with writing global regulatory applications in CTD format...
., GxP, FDA, EMA). Mentor junior consultants and ensure delivery quality across distributed teams Support business...
regulatory expectations (FDA, EMA, etc.) Strong knowledge of root cause analysis and quality risk management principles (ICH Q9...
, Washington, Allegheny, Venango, Forest, and Crawford counties. The consultant will liaise with local elected officials, EMA...
in this position may operate any/all of the following equipment: Microsoft 365 apps, fax, email, phone, Klara, EMA, ModMed, iPAD...
worldwide — including interactions with the FDA, EMA, and other regulatory bodies — while serving as the primary device... authorities, including the FDA and EMA, with the ability to represent the organization confidently in agency meetings. Fluency...
and Regulatory Biomarker Leadership: Provide senior oversight for late-phase studies, aligning biomarker strategies with FDA/EMA... for companion diagnostics (FDA/EMA). Digital pathology, AI/ML, or multi-omic biomarker integration experience. Strong...