Scheduler
cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic...
cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic...
analytics software tools (e.g., JMP, R, Python) Regulatory experience and knowledge of FDA/EMA regulations related to drug...
techniques. Ø Certification or Knowledge of Current Good Manufacturing Practice, FDA 21 CFR Part 11, and EMA EU GMP Annex 11...
. Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations...
discipline. 7 years of transferrable experience. Practical knowledge of the application of FDA GMP and EMA regulations. Expert...
-functional teams, auditors, and regulatory authorities. Experience supporting regulatory inspections (FDA, EMA...
EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central...
(EMA), and functional magnetic resonance imaging (fMRI) to understand individual and environmental factors that influence...
identification, precision medicine etc.). Excellent understanding of FDA/EMA guidance within the TA. * Ability to communicate...
. External US: About This Role The Sr. Specialist, Regulatory Affairs, provides critical insights on FDA and EMA expectations... and appropriate involvement in working groups. Provides expert insights on FDA and EMA expectations to guide organizational decision...