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...
use of cryotherapy Experienced using EMA (Dermatology EMR) Experience seeing 30 to 40 patients/day Benefits Competitive base...
labeling Knowledge of labeling within a Therapeutic Area Knowledge of FDA, or EMA, or other international regulations...
environment (ICH/Compendial/FDA and EMA). Responsibilities: Main focus: The Manager/Senior Manager of CMC QC will work... that all QC activities comply with regulatory requirements, including those of the FDA, EMA, and other relevant agencies. Method...
, EMA). Project Management Professional (PMP) certification with proven success with external partnerships...
; communicate any issues or risks proactively. Ensures compliance with FDA, EMA, and global regulatory requirements; assures the...
requirements (e.g., FDA, EMA) Experience with manufacturing processes such as lyophilization, crystallization, filtration...
responders and ecological momentary assessment (EMA) methodologies. Data Analysis, Manuscript Preparation, & Writing: Develops...
, Lab Equipment Validation, quality system, Change Control, Deviation, CAPA, Asset Standardization, OEM, FDA, EMA, Auto Desk... within an FDA/EMA regulated environment. Auto Desk Fusion 360 or SolidWorks experience preferred. Experience in CAD design...
requirements (FDA, EMA, ICH, etc.) and industry standards (GMP, GLP, GAMP, etc.) related to CQV. Experience with risk...