JOB TITLE: REGULATORY AFFAIRS MANAGER II
CAREER LEVEL: D
Role Type: Individual Contributor for Global Markets

ABOUT ASTRAZENECA
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most responsible diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we 're dedicated to being a Great Place to Work.

ABOUT THE ROLE

Description:
The Regulatory Affairs Manager II is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned global deliverables in the maintenance Center of Excellence, as an individual contributor. The Regulatory Affairs Manager II may have to take on the accountabilities for a number of different roles within a Global Regulatory Execution Team (GRET).



The Regulatory Affairs Manager II is expected to be able to work flexibly to deliver these varied accountabilities as assigned to them by their Portfolio director.
The Regulatory Affairs Manager II is fully proficient in applying established standards to perform regulatory affairs management for moderately complex products/regions and under minimal supervision. Capable of leading cross functional activities. Participates in continuous improvement of process and tools/systems.

Regulatory Affairs Management
Contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. Provides regulatory expertise and guidance on procedural and documentation requirements to GRET and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
Provides regulatory labeling expertise and leads the maintenance of global labeling documents for Established brands. Is

📌 Regulatory Affairs Manager II (Bengaluru)
🏢 AstraZeneca
📍 Bengaluru