Beata Augustyniak

Short term contract where I assisted Regulatory Submissions Group in its peak submission time.

• Prepared, built, published and validated eCTD regulatory submissions for EMA, other EU national health authorities and for Swissmedic, FDA and ROW. • Worked with: MAA, CTA, IND, NDA, variations, corrigenda, FUM/PAM, renewals, safety reports (RMP, PSUR, DSUR), clinical reports, protocols and amendments. • Adhered to requirements of ICH, EC, EMA, FDA, Swissmedic. • Submitted regulatory submissions via eSubmission Gateway, CESP, FTP and dispatched CDs/DVDs. • Coordinated regulatory translations.

• Published eCTDs for EMA, Swissmedic and FDA submissions. • Formatted, edited, created bookmarks and hyperlinks, scanned and rendered PDFs, quality control checks on documents ready for electronic and paper regulatory submission. • Worked with cross-functional teams. • Ensured that all regulatory documentation is archived in EDMS and in paper in Clinical Records Repository. • Prepared regulatory documentation for inspections / audit.