of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biological products...
, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles. Understanding medical terminology and statistical...
between regionally positioned warehouses in Americas, EMA, and Asia Pacific. Design, develop and integrate process improvements... team members in AP and EMA regional warehouses. Supervision The position is managerial in nature as it requires daily...
: Ensure all master data practices meet global regulatory standards, including FDA, EMA, GMP, and other pharmaceutical industry... with regulatory requirements such as FDA, GMP, and EMA Strong leadership skills with a proven track record of building and managing...
years in a leadership position. Comprehensive understanding of CMC regulations and guidelines, particularly FDA and EMA...
: Ensure that all clinical data management activities are compliant with regulatory requirements, including FDA, EMA... Knowledge: Deep understanding of regulatory standards, including FDA, EMA, and ICH-GCP guidelines...
of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical...
with interacting with medical diagnostic regulatory bodies (e.g. FDA, PMDA, EMA). Experience with Python programing and Python data...
analysis and reporting meet industry regulations, such as FDA guidelines, EMA standards, or ICH guidelines. You’ll work.... Regulatory Knowledge: Familiarity with regulatory requirements for pharmaceutical data, including FDA, EMA, and ICH guidelines...
analysis and reporting meet industry regulations, such as FDA guidelines, EMA standards, or ICH guidelines. You’ll work.... Regulatory Knowledge: Familiarity with regulatory requirements for pharmaceutical data, including FDA, EMA, and ICH guidelines...