JOB PURPOSE
Lifecycle Management of Existing Products
Plan, prepare, and submit regulatory variations for marketed products, including CMC changes, labeling updates, and maintenance of product licenses, ensuring ongoing regulatory compliance.
Support for Regional and Global Regulatory Projects
Manage and execute assigned regulatory projects and activities requested by regional and global stakeholders, ensuring timely delivery and alignment with business objectives.
Regulatory Issue Management
Identify, assess, and address regulatory issues related to assigned products, providing regulatory guidance and coordinating with internal and external stakeholders as needed.
RESPONSIBILITIES
Manage regulatory lifecycle activities for marketed products including shelf-life extensions, CMC variations, manufacturing site transfers, GDS updates, renewals, and other post-approval c...