Oversight Monitor
(E6 R2/R3), applicable regulatory requirements (such as FDA, EMA, Health Canada, MHRA), and the sponsor’s Quality...
(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...
for a pharmaceutical organization. Ensure compliance with industry regulations (FDA, EMA, GMP), drive process standardization, and enable...
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...
in formulation development and drug stability according to ICH, FDA, and EMA standards. Prepare and maintain accurate records...
a safe working environment in the laboratory. Ensure compliance with international regulations such as FDA and EMA. Work...
with drug development in biologics, targeted therapies, and companion diagnostics preferred Experience working with FDA, EMA...
environment in the laboratory. Ensure all work is compliant with international regulations, such as FDA and EMA. Work with R...
of EMA highly preferred Must have current hands-on clinical experience Must have experience with sterilization...