Regulatory Affairs Manager

仕事内容

• Proactively contribute to the strategy, direction and efficient delivery of drug projects
• Leads or participates as a member of cross-functional global business projects, providing expert regulatory advice
• Provide timely, constructive feedback and coaching AZ colleagues
• Leads the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
• Leads or participates as a member of cross-functional global, regional or local brand/delivery teams for complex submissions, providing expert regulatory advice
• Identifies potential complex regulatory risks to the global and regional operational plans, and propose options to mitigate risks.
• Provides regulatory expertise on global and regional regulatory submissions, health authority briefing documents and response documents.
• Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration