. Expert knowledge of FDA, EMA, ICH, and global GMP/GxP regulations. Proven track record managing supplier quality programs...
support functions. Adherence to all cGMP requirements, a basic understanding of FDA/EMA regulations, effective interactions...
Health Authorities (e.g., FDA, EMA, PMDA, CDE) Demonstrated ability leading and motivating teams in a matrix environment...
position will be primarily focused on research recruitment, acquiring behavioral, app-based, EMA data, and database management... research- based mobile app, tracking completion of EMA data), data collection (computer-based, mobile app), and database...
authority PV/GVP inspections, including FDA and EMA inspections where applicable. Strong knowledge of global safety and PV... regulatory requirements, GVP, FDA, EMA, ICH guidance, and applicable international regulations across clinical development...
analyses for submissions. Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA...
’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility...
requirements, including FDA, EMA, ISO, and country-specific standards. Proactively monitor regulatory and industry changes...
/ Americas), including side-by-side analysis and documentation of recommendations, decisions, and post-EMA harmonization... timelines. * Support post-Day 1 and post-EMA harmonization activities Drive post-EMA harmonization opportunities identified...
such as EMA and MHRA) and industry best practices (e.g., CDISC Trial Master File Reference Model). Partner with subject-matter..., EMA, MHRA). Thorough understanding of ICH- GCP guidelines and regulatory requirements as they apply to the TMF...