Regulatory Manager | Labeling | DSCSA
Manage workflow of the labeling department. Set daily priorities and timelines. Work with upper and project management to establish timelines to meet patent expiry, support drug shortages, responses to deficiencies, post-market and regulatory submissions.
Final review and approval of submission, deficiency response, initial launch, RLD updates and post-approval labeling packages.
A lead team member to assist in the companies implementation of the 2017 Track and Trace serialization (DSCSA) initiative. Understanding the laws published by Congress and FDA leading the preparation with company, partner, label and software readiness. Serving as main contact for regulatory interpretation and label updates not limited to regulatory, tooling and data/validation requirements.
Developed labeling projects with 20+ domestic and foreign partners including new ANDA development, third party labeling, joint ventures and private labeling (Novation, Premier, AmerisourceBergen). Includes the request and review of dyelines, barcode creation, and the request and review of all label claims and other forms from all partners.
Practical and working knowledge of drug listing, metadata reviews, submission SPLs, and establishment registrations.
Process owner of establishing new NDC numbers.
Full ownership and responsibility of the monitoring and communication of design label updates to those inside and outside of the organization. Ensure timely implementation of updated labeling components.