Warning letters, 483s, Recalls, Import Alerts, Audit observations
Compilation and submission of dossiers, Maintain databases, Change control review, Support Global Project Management team
The role involves maintaining regulatory databases, supporting document compilation, and coordinating required documentation for regulatory
Life cycle management of product registrations, dossiers, handling of variations for Europe
Regulatory submission of new products, renewals, variations, response to queries and Life cycle management for
Compilation and review of dossiers, DMF for US, Europe, Japan and other markets , Evaluation
