documentation Knowledge of regulatory guidelines, including GCP/ICH, FDA/EMA/CHMP, 21 CFR Part 11, validation requirements...
past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies...
with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites...
(e.g., FDA, EMA) and company standards Stay updated with regulatory guidelines, industry trends, and best practices...
past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies...
of sterilization processes. Ensure compliance with relevant regulatory guidelines, including FDA, EMA, and ISO standards. Provide...
case-processing and reporting. Strong knowledge of current and emerging regulatory requirements including EMA GVP Modules...
safety processes for clinical trials Knowledge of GCP, FDA, MHRA and EMA regulatory requirements for clinical trial...
and applicable FDA/EMA Guidance;Collaborate with manufacturing, engineering, facilities, and quality assurance to Responsible...
% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial...