for a CMC submission and design the product strategy accordingly. Ensure the company has the right analytical expertise... development phases (discovery to launch) across global markets Wide ranging experience of interactions with global regulatory...
Join our global team at AstraZeneca as a CMC Regulatory Affairs Senior Director & Group Manager. This role... is an outstanding opportunity to lead a team of regulatory professionals, providing strategic technical CMC regulatory expertise...
across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted... across relevant groups, including Clinical Development, Preclinical Development, Marketing and CMC. Lead and work closely...
from pre-clinical through clinical studies to initial registration in key global markets, of pharmaceutical diagnostics... document (GRSD) delivery. · Knowledge of preclinical, CMC, clinical related regulations/guidance as it relates to development...
markets and understanding of drug development, CMC and supply chain regulations. Key Responsibilities: Leads the...
Safety, Trade Operations & Supply, Legal, Medical Affairs, Finance and Access), Regulatory Therapeutic Area and CMC Liaisons... regulatory affairs across international markets, including regulatory submission experience and a good understanding of the drug...