relationships in and outside the organization. Strong understanding of cGMP, FDA, EMA, and other relevant regulatory requirements...
manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP...
their EMA/TGA. You will review the deliverables so they remain on target. Beyond the scope of the contract, your team...
with: interacting with Health Authorities, including FDA or EMA (European Medicines Agency), during inspections; working with Regulatory...
guidelines (e.g., ICH, FDA, EMA) Experience with cold chain management for global distribution of clinical products...
within a pharmaceutical or CRO setting. Strong knowledge of regulatory guidelines (GLP/ICH, FDA, EMA, etc.) governing bioanalytical testing...
with international quality requirements as defined by the FDA, EMA and other regulatory agencies as applicable. To achieve compliance...
, fully integrated EMR (EMA) and we employ the area’s best, top quality administrative and clinical support staff. At Anne...-of-the-art-technology,including EMA/ModMed Exceptional administrative support Sign on bonus/relocation assistance...
, EMA and MHRA regulations and guidelines regarding GCP, GLP and GVP activities Excellent verbal and written communication...
two manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10...