. * Serve as site SME for reference standards during internal audits and regulatory inspections (FDA, EMA, and others) — back...
changes is a plus Experience with Health Authority interactions is desirable Thorough understanding of major FDA, EMA...
stakeholders. Demonstrates advanced knowledge of FDA / EMA regulations, NDA and other regulatory requirements, and web-based EDC...
use Modernizing Medicine - EMA) Maintain adaptable and functional computer skills Respond to emergency situations based..., required SECTION 4: Knowledge, Skills and Abilities Requirements Thorough knowledge of medical terminology - required Prior EMA...
Deep understanding of pharmaceutical drug development, clinical operations, and regulatory requirements (FDA, EMA, GxP, 21...
) and applicable regulatory guidelines (FDA, EMA, etc.) in a clean room environment requiring aseptic behavior. Prepare media...
: Advanced knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Gene/Viral therapy products...
in accordance with study timelines. Ensure compliance with ICH-GCP, FDA, EMA, and other applicable regulatory requirements...
preferred. Experience working within FDA, EMA, MHRA, and other global regulatory frameworks. Proven ability to lead cross...
regulatory bodies (FDA, EMA, MHRA). Deviation, CAPA & Investigations Document and track stability-related deviations (e.g...