(GMP), regulatory standards (FDA, EMA, ICH), and company policies. Responsibilities: Key Responsibilities: New Product... and international Strong knowledge of regulatory requirements (FDA, EMA, ISO). Excellent problem-solving and critical-thinking skills...
/EMA data integrity principles (ALCOA+) and computer system validation (CSV) under GxP/GMP standards. Manage multiple...
resources for project management & execution. Ensure digital solutions comply with FDA/EMA data integrity principles (ALCOA...
with the EMA review process concluded positively in September 2023. It is an exciting time in the company’s development...
, and Q10), FDA, EMA, USP, EP, and JP. Experience in root cause analysis and risk analysis Good project management, problem...
a professional demeanor at all times. Some duties include reviewing medical documentation for accuracy, using EMA EMR to document...
(i.e., CCDS), and local labels Representing global patient safety at regulatory inspections (e.g., MHRA, FDA, EMA) Messaging...
: Knowledge of regulations associated with ICH Guidelines (Q7, Q8, Q9, and Q10), FDA, EMA, USP, EP, and JP. Experience in root...
’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility...
Experience utilizing Modernizing Medicine/EMA EMR highly preferred Demonstrated alignment with Optima Dermatology's mission...