Compile and perform initial review of US labeling documents for:
Original ANDA submissions
Additional strength submissions
Coordinate with Cross-Functional Teams (CFTs) to ensure alignment on priorities, roles, and regulatory filing timelines.
Proactively follow up with internal stakeholders to obtain labeling documents within defined timelines and ensure completeness of all labeling modules prior to submission.
Stay current with US labeling regulations, FDA guidance, and industry best practices.
Ensure availability and readiness of all labeling modules for:
Complete Response (CR)
Information Request (IR)
Deficiency Response Letter (DRL) submissions Coordinate with cross-functional teams to collect and compile required documents for responses.
Ensure 100% launch readiness for all new products with zero labeling-related issues, including:
Issuance of most current, approved labeling (Ok-To-Print)
Timely availability of printed labeling for product launch
Drug listing completion for first-launch products post-approval
Assist in reviewing Reference Listed Drug (RLD) labeling updates for OSD and Injectables and ensure timely submission of updated labeling modules. Coordinate with supervisor to align priorities.
Initiate and facilitate Change Controls and Labeling Review Committee (LRC) activities for all labeling changes.
Address and track annual reportable labeling changes.
Manage Safety Labeling Change Notifications in compliance with regulatory requirements.
Demonstrate strong knowledge of Patent and Exclusivity considerations, including labeling carve-outs.
Support development, revision, and compliance of labeling SOPs.
Required Skills & Competencies
Strong understanding of US FDA labeling regulations for OSD and Injectable products
Excellent written and verbal English communication skills
Strong coordination, follow-up, and documentation skills
High attention to detail with the ability to manage multiple priorities effectively
