Supervisor, Central Services
EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central...
EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central...
(EMA), and functional magnetic resonance imaging (fMRI) to understand individual and environmental factors that influence...
identification, precision medicine etc.). Excellent understanding of FDA/EMA guidance within the TA. * Ability to communicate...
. 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 transferrable experience. Practical knowledge of the application of FDA GMP and EMA regulations. Expert in industrial utility...
of relevant FDA/EMA regulations Plans schedules and arranges own activities when accomplishing objectives Must be able to deal...
Bioanalytical project data for submission to e.g., FDA, EMA; Prepare and review Protocols, SOPs, Forms, IQ/OQ/PQ documents...
. 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...
, EMA, ICH guidelines). Proven track record of successfully managing and engaging international/cross-cultural teams...
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...