Deborah Goff Email & Phone Number

Greenville, NC, US

Tarrytown, New York, US

• Manage the development, revision, preparation and internal approval of packaging artworks e.g., carton, container label, printed package inserts for assigned development products as well as marketed products. Maintain.
• Provide functional expertise at relevant department meetings and relevant cross functional sub-teams.
• Lead packaging team to ensure packaging content and artworks are compliant with internal labeling policies, standard operating procedures and worldwide health authority regulations.
• Contribute and manage Annual Reports for assigned products.
• Maintain and track packaging artwork lifecycle and documents in appropriate labeling repository and electronic systems.
• Manage and review preparation of SPL.

Raleigh, North Carolina, US

• Provided labeling operations expertise, leadership and guidance to internal and external stakeholders in the successful development, submission, and implementation of CCDS, US and EU labeling.
• Implemented internal or client procedures, processes or programs that resulted in continuous improvements for labeling activities and business requirements.
• Worked cross-functionally to ensure client labeling objectives are met. Monitor progress, identify risks and propose solutions for improvements.
• Formulated strategies for the submission and implementation of new and revised labeling.
• Provided expert advice on current labeling requirements, industry trends, templates, tools, systems, medical and regulatory regulations and guidance documents.
• Supported ICON/PRA and client activities associated with IT systems and technology.

Paris, France, FR

Cambridge, Cambridgeshire, GB

• Serve as Labeling Strategist, Lifecycle and US Labeling Delivery Manager for all authorized generic product development projects.
• Responsible for the regulatory role as part of the process for coordination, development and implementation of new and revised printed labeling for assigned commercial products and devices.
• Author and trainer of authorized generics program for labeling creation and product launch.
• Ensure all work is performed in accordance with established procedures and regulatory requirements.
• Point of contact for the management of all labelling/artwork requests that require market/regulatory approval in US, (i.e., creation, approval, and implementation of commercial printed labeling in collaboration with.
• Coordinate and/or lead the development and lifetime maintenance of packaging component labeling for commercial products, including introduction of new packs and new product launches, updates to existing packs, and.

Basel, Basel-Stadt, CH

• Managed end-to-end labeling compliance for the Sandoz Wilson manufacturing site from development of Core Data Sheets (CDS) to withdrawal of product from the FDA Orange Book.
• Team leader of three labeling specialists. Managed workload assignments and provided labeling guidance.
• Authored, implemented and maintained current labeling processes and procedures.
• Collaborated with Regulatory Affairs Chemistry, Manufacturing, and Control (RA CMC) Associates regarding labeling changes for FDA submissions.
• Advanced knowledge of current Good Manufacturing Practices (cGMPs), Structured Product Labeling (SPL), Code of Federal Regulations (CFRs), Track and Trace, electronic Common Technical Document (eCTD).
• Authored FDA labeling submissions and submitted drug listings according to Code of Federal Regulations (CFR) requirements.

• Supervised Packaging Engineers in the acquisition of all packaging component artwork.
• Coordinated development, approval and distribution of all packaging component artwork, proofs and color standards between outside graphics contractors, customers and suppliers for all existing drug products and new.
• Provided graphics creation support/typesetting to customers that require graphics services.
• Effectively communicated with customers, suppliers, outside graphics contractors and internal departments to develop and approve artwork and quickly resolve issues regarding the artwork/proof process.
• Acted as a knowledge resource in relation to regulatory guidelines pertaining to packaging graphics.
• Prepared artwork for production and test packaging components using appropriate graphics software.

Msa, Information Resources Management

R.A.C., Regulatory Affairs Certification

B.S., Business Administration: Organizational Development And Management

A.A.S, Business Administration