Senior Executive, Labeling Reviewer

Key Responsibilities:

• 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

Master's Degree