of global regulatory requirements (e.g., US FDA, EMA). Proficiency in project management tools such as SmartSheet or Monday...
-functional teams. Comprehensive understanding of global regulatory requirements (e.g., US FDA, EMA). Proficiency in project...
, EMA, ICH, ISO 9001, 21 CFR 210/211). This role builds and maintains compliant quality systems, drives inspection...
across clinical and commercial programs, ensuring alignment with global regulatory expectations (FDA, EMA, ICH, etc.) supporting R...
qualifications: Experience managing QC aspects at external partners like CMOs, familiarity with US, EU, EMA, and FDA regulatory...
and system upgrades. · Understanding of FDA and/or EMA quality and regulatory processes. Prior experience with regulatory...
/ week) split between two nearby clinics less than five miles apart Established systems using EMA / EMR to support...
audiences (internal and external). Knowledge of medical affairs processes, regulatory compliance (GCP, FDA/EMA...
audiences (internal and external). Knowledge of medical affairs processes, regulatory compliance (GCP, FDA/EMA...
gene therapy campus in Harmans, MD—just minutes from BWI Airport—features EMA and FDA-approved manufacturing suites, fill...