and Validation Support: · Ensure the ValGenesis system complies with regulatory standards (e.g., FDA, EMA, GxP) and internal...
regulations (21 CFR Part 312), EMA Compassionate Use frameworks, and international regulatory requirements. Demonstrated vendor...
capabilities. As part of a small, operational EMA team, the successful candidate will also support EOC activations, exercises...
/EMA regulatory expectations. Understanding of pharmaceutical manufacturing processes and cleanroom operations...
deadlines in a fast-paced environment. Familiarity with regulatory guidelines such as FDA, EMA, ICH, GxP, and publication...
regulations and guidance. ·Knowledge and proven experience in FDA, EMA, or other regulatory authority. ·Well-practiced...
from an accredited agency desired Strong knowledge of cGMP, ISO 13485/9001, and applicable regulatory requirements (FDA, USDA, EMA...
, GDP, and FDA/EMA regulatory expectations. Understanding of pharmaceutical manufacturing processes and cleanroom...
working knowledge of cGMP, GDP, and FDA/EMA regulatory expectations. Understanding of pharmaceutical manufacturing processes...
/ EMA regulations, NDA and other regulatory requirements, and web-based EDC and CDM systems, as evidenced by increasing...