knowledge of the application of FDA GMP and EMA regulations. Expert in electrical power supply and distribution. Experience...
: Functional knowledge of GMPs and applicable FDA, EMA, Health Canada, USP, ICH and PDA guidelines This job posting...
of FDA and EMA regulations, ICH guidelines, and GCP governing the conduct of clinical studies. Has significant knowledge...
use of cryotherapy Experienced using EMA (Dermatology EMR) Experience seeing 30 to 40 patients/day Benefits Competitive base...
and Module 3) for global marketing and post-approval applications. Strong knowledge in global regulatory (FDA, EMA...
% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role...
manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP...
direct contact/liaison with FDA/EMA, for new or marketed chemical entities, biological entities, vaccines. The incumbent... relationships. Responsible for direct contact/liaison with US FDA and EMA on specific CMC topics. Supports strategic negotiations...
experience and/or academic research. Has in-depth knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity...
preparations (imaging, IRT, labs) for potential inspections For the actual site inspections by FDA/EMA, etc at our sites, assist... Strong knowledge of ICH/GCP and current regulatory guidelines/directives, with experience with FDA (BIMO manual), EMA...