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 strategy
Develop and maintain Core and market product information
Guide product labeling teams through senior leader approval
Interpret regulations, guidance, trends, and competitor analyses
Communicate labeling rationale, risks, and mitigations to collaborators
Requirements
University degree in science or related discipline
Three to five years pharmaceutical and regulatory experience
Knowledge of labeling regulations and guidance
Excellent verbal and written communication skills
Strategic thinking, risk assessment, and negotiation abilities
Bring pharmaceutical regulatory expertise, strategic judgment, and accurate communication to AstraZeneca’s global labeling work in Mississauga.