reviews, and documentation strategy. Ensure alignment to applicable regulations and guidance such as FDA, EMA, ICH, and site...
, relevant EU regulations and GMP guidance, ICH guidelines, and applicable FDA and EMA expectations. Experience interacting...
interactions with global health authorities (FDA, EMA, PMDA and other agencies), including briefing packages, meeting preparation... drug development experience is highly desired. Regulatory submission (US FDA, EMA, PMDA) experience is highly desired...
) in accordance with GCP, FDA, EMA, ICH, and NIH standards. Maintain and manage accurate documentation for DSMB charters, rosters...
(FDA, EMA, MHRA) for AI/ML in drug development. At the Senior Scientist level, you will additionally be expected to shape...
experience with 1+ years of manufacturing site experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell...
applicable FDA, EMA, ICH, and country-specific regulatory requirements and timelines. Monitor submission compliance...
values Advanced systems including Modernizing Medicine’s EMA for efficient EMR and practice management Flexible...
, such as ad hoc data mining of FDA FAERS, WHO VigiBase, and EMA EudraVigilance databases. Support exploration of new signal...
therapeutics (ICH, FDA, EMA) highly preferred. Statistical knowledge and hands-on experience with design of experiments, stability...