Associate Director, Engineering
-functional teams, auditors, and regulatory authorities. Experience supporting regulatory inspections (FDA, EMA...
-functional teams, auditors, and regulatory authorities. Experience supporting regulatory inspections (FDA, EMA...
. External US: About This Role The Sr. Specialist, Regulatory Affairs, provides critical insights on FDA and EMA expectations... and appropriate involvement in working groups. Provides expert insights on FDA and EMA expectations to guide organizational decision...
of relevant FDA/EMA regulations Plans schedules and arranges own activities when accomplishing objectives Must be able to deal...
within the Emergency Management Agency (EMA) & supervise Public Safety Intelligence Analysts, conduct analytical product reviews... to Ohio EMA leadership & partners in Ohio's emergency management, public safety, & homeland security communities; · Conduct...
(EMA), and functional magnetic resonance imaging (fMRI) to understand individual and environmental factors that influence...
, EMA, ICH guidelines). Proven track record of successfully managing and engaging international/cross-cultural teams...
identification, precision medicine etc.). Excellent understanding of FDA/EMA guidance within the TA. * Ability to communicate...
. Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations...
EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central...
techniques. Ø Certification or Knowledge of Current Good Manufacturing Practice, FDA 21 CFR Part 11, and EMA EU GMP Annex 11...