, including having played a lead role in more than one IND/IMPD, BLA/NDA/MAA filing and in Advisory Committee or other PMDA/EMA... major regulatory filings – IND/IMPD, BLA/NDA/MAA. Experience leading preparation of PMDA/EMA/FDA milestone meetings...
and successfully oversaw a strong launch in February to the US market with the EMA review process concluded positively...
experience required) Strong knowledge of global PV regulations (FDA, EMA, ICH) Experience in safety surveillance, signal...
Strong knowledge of global regulatory requirements (FDA, EMA, ICH, etc.). Proficiency in safety databases (e.g., ARISg, Argus...
Leadership Proactively monitor and interpret evolving FDA, EMA, and global labeling regulations, guidances, and enforcement..., JD) Experience supporting product launches and/or major label expansions Global labeling experience (FDA, EMA...
with EMA Director, and Morgan County Public Safety leaders, and local government leaders in areas relating to Health Department... of coordinating and responding to public health emergencies and rendering service. Incumbent reports directly to EMA Director...
. Regulatory Expertise: Knowledge of FDA (CFRs), EMA, and ICH regulations, specifically regarding 21 CFR Part 11 compliant GMP...
development phase, including but not limited to: understanding IND submission requirements of the U.S., China, and EMA;evaluating...
and compliance Working knowledge of FDA, EMA, and global PV Regulations, and application of Good Pharmacovigilance Practices (GVP...
technical experience with FDA, EMA, PMDA, CFDA, and global regulations as they relate to analytical methods, control strategies...