. Knowledge of regulatory requirements and guidelines (e.g., FDA, EMA) related to cGMP. Preferred Education: Master's degree...
with FDA, EMA, and internal SOPs. Lead QA review and approval of analytical development, qualification and validation as well...
, ICH Q10) and experience interacting with multiple health authorities (e.g., FDA, EMA, PMDA). Must have a sustained mindset...
), communicate mitigation plans, and escalation pathways and ensure compliance with applicable regulations (e.g., ICH GxP, EMA, FDA...
, such as USFDA, cGMPs and EMA guidelines. Demonstrate commitment to continuous improvement by proactively adopting new strategies...
lifecycle regulatory requirements and industry standards (e.g. GCP ICH FDA/EMA expectations). Experience working in a highly...
required Document reviews in relevant systems with a focus on inspection readiness Working knowledge of relevant GCPs and FDA, EMA...
and ecological momentary assessment (EMA) data on human-rodent interaction Working in R or similar tools to produce summaries...
11, EMA Annex 11, and core quality workflows. Preferred Qualifications Masters Degree in a relevant technical field...
patient history, visit reason, medications, and patient understanding of procedures, and make notes in EMA. Ensuring MIPS...) EClinicalWorks, EMA, or other EMR software Exciting Perks: 40% off products and procedures, as well as the ability to participate...