• Manage labeling transition project requiring revision and implementation of over 650 individual product labels and package inserts.• Research, recommend, and lead implementation of new quality system for artwork management.• Manage the regulatory aspects (for over 150 approved and development drug products) of product advertising, promotional materials, and labeling for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).• Collaborate with internal and external groups to ensure successful submission and implementation strategy for new and existing product labeling.• Prepare and submit labeling submissions in response to FDA requests, deficiencies, or internal revisions. • Manage labeling for 3rd party collaborations between RLI and contract manufacturing organizations.• Investigate and recommend response to customer product complaints.• Oversee onboarding and inter-departmental training of regulatory analysts as pertains to labeling.• Directly communicate with FDA labeling reviewers to ensure labeling compliance.• Attend and share information from industry-related meetings, seminars, and training workshops.• Subject Matter Expert for intercompany labeling questions.

• Create, revise, and review FDA compliant artwork for portfolio of drug products throughout lifecycle (development through post-approval).• Review FDA deficiency requests and recommend appropriate response for labeling content.• Create and review package insert content for Drug Listing in SPL format.• Execute change control for new and revised package inserts and other printed packaging components.

• Use provided technical data to create labeling content for new FDA submissions.• Review and approve vendor proofs prior to final print production to ensure error free product labeling.• Prepare and make graphical changes to existing artwork based on internal or external requests.

• Assist in the preparation and submission of all INDs, ANDAs and amendments to FDA including paginating, tabbing, copying, quality checking, and assembling all documents.• Organize and update files of approved ANDAs, amendments and all other correspondences with FDA and Clinical Research Organizations• Maintain budget information for all ongoing research and consulting services. Responsible for payment and tracking of all incoming invoices.