Regulatory Labeling Strategy Associate Director

Lead regulatory labeling strategy for complex drug projects at AstraZeneca in Mississauga, with hybrid work three days weekly and global collaboration.This Associate Director provides labeling expertise to global submission, execution, and product labeling teams. You will develop and maintain Core Product Information and United States and European Union market information for marketed or pipeline products. The role includes mentoring peers and supporting labeling group development.Key Responsibilities:
Lead labeling strategy aligned with overall product regulatory strategyDevelop and maintain Core and market product informationGuide product labeling teams through senior leader approvalInterpret regulations, guidance, trends, and competitor analysesCommunicate labeling rationale, risks, and mitigations to collaboratorsRequirements:
University degree in science or related disciplineThree to five years pharmaceutical and regulatory experienceKnowledge of labeling regulations and guidanceExcellent verbal and written communication skillsStrategic thinking, risk assessment, and negotiation abilitiesBring pharmaceutical regulatory expertise, strategic judgment, and precise communication to AstraZeneca’s global labeling work in Mississauga.
#J-18808-Ljbffr