guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Arcus Standard...
for a pharmaceutical organization. Ensure compliance with industry regulations (FDA, EMA, GMP), drive process standardization, and enable...
design, biostatistics, data management, and risk-based monitoring. Experience in submission processes for FDA, EMA, and IRB...
(E6 R2/R3), applicable regulatory requirements (such as FDA, EMA, Health Canada, MHRA), and the sponsor’s Quality...
a safe working environment in the laboratory. Ensure compliance with international regulations such as FDA and EMA. Work...
regulations and standards, including FDA regulations and ISO 13485 and GMP. Demonstrated experience of preparing US FDA/EU EMA...
(FDA, EMA, ICH GCP) Partner with Clinical Sourcing, Supplier Quality, and Clinical Operations to oversee vendor compliance..., FDA/EMA regulations, SOPs, QMS, and compliance documentation. Ability to collaborate with global clinical teams...
a safe working environment in the laboratory. Ensure compliance with international regulations such as FDA and EMA. Work...
in formulation development and drug stability according to ICH, FDA, and EMA standards. Prepare and maintain accurate records...
environment in the laboratory. Ensure all work is compliant with international regulations, such as FDA and EMA. Work with R...