Selection, and Approvals and Continuous Improvement. Provides support and interfaces directly/indirectly with the FDA, EMA, MHRA...
knowledge of PV regulations: FDA (21 CFR 312.32, 314.80, FAERS), EMA GVP (Modules VI, VII, IX), and ICH E2 (E2A-E2F). Direct... (Big 4 or life sciences consultancies) in PV projects. Involvement in regulatory inspections (FDA/EMA GVP), and audit...
Ensure quality operations comply with global regulatory requirements (e.g., FDA, EMA, PMDA) and internal standards. Support...
with FDA, EMA, and internal quality requirements. As representatives of the GMP Training function, you will be working...
expertise in regulatory and compliance requirements for microbiological methods and specifications, including ICH, FDA/EMA...
-centric development principles, industry best practices, and regulatory expectations (including those of US FDA, EMA/NBs, UK...
of relevant GxPs as well as applicable multinational regulatory guidelines, e.g., EMA, FDA, PMDA Significant experience managing...
regulatory frameworks and standards (e.g., GDPR and other privacy laws, NIS2, HIPAA, FDA/EMA expectations, ISO/IEC 27001/27701...
to clinical development are highly desirable. Understanding of FDA, EMA and ICH regulations and guidelines. Experience working...
, Coder) and their integrations preferred. In-depth knowledge of ICH-GCP, FDA/EMA regulations, and GCDMP. Strong expertise...